Abstract
Background
Coma and vegetative state follow traumatic brain injury in about one out of eight patients, and in patients with non traumatic injury the prognosis is worse. The use of sensory stimulation for coma and vegetative state has gained popularity during the 1980's but beliefs and opinions about its effectiveness vary substantially among health professionals.
Objectives
To assess the effectiveness of sensory stimulation programmes in patients in coma or vegetative state.
Search methods
We searched the Injuries Group specialised register, the Cochrane Controlled trials register, EMBASE, MEDLINE, CINAHL and PSYCHLIT from 1966 to January 2002, without language restriction. Reference lists of articles were scanned and we contacted experts in the area to find other relevant studies.
Selection criteria
Randomised or controlled trials that compared sensory stimulation programmes with standard rehabilitation in patients in coma or vegetative state.
Data collection and analysis
Abstracts and papers found were screened by one reviewer. Three reviewers independently identified relevant studies, extracted data and assessed study quality resolving disagreement by consensus.
Main results
Three studies were identified with 68 patients in total. The overall methodological quality was poor and studies differed widely in terms of outcomes measures, study design and conduct. We therefore did not carry out any quantitative synthesis but reviewed results of available studies qualitatively.
Authors' conclusions
This systematic review indicates that there is no reliable evidence to support, or rule out, the effectiveness of multisensory programmes in patients in coma or vegetative state.
Plain language summary
No strong evidence about the effects of sensory stimulation for a brain‐injured person in a coma
About half of people in a coma (deep unconsciousness) because of traumatic brain injury will wake within a year of the accident. Speeding recovery to allow people to wake sooner is a priority for them and their family. One type of treatment uses sensory stimulation to try to keep the person's brain working normally. Sensory stimulation methods vary greatly, from one or two hourly sessions of a day, through to shorter sessions every hour for 12 to 14 hours a day. The review found there is no strong evidence to determine whether sensory stimulation benefits people in comas.
Background
Prolonged coma and vegetative state follow severe traumatic brain injury in about one of eight patients with severe closed‐head injury assessed at discharge from a Trauma Centre (Levin 1991). According to the Traumatic Coma Data Bank, 52 per cent of the vegetative survivors from severe head trauma regain consciousness within one year post‐injury and 40 per cent improve to a higher Glasgow Outcome Scale within six months (Task Force on PVS). The remaining individuals die or remain in a vegetative state for months or years.
The outcome for individuals in coma or vegetative state with non‐traumatic brain injury is worse than that for those with traumatic brain injury (Sazbon 1993). In one trial, of 100 patients, 20 recovered consciousness within five months, 31 had died by six months after onset, and 49 remained unconscious for the remainder of their lives. Only seven individuals were alive after 72 months of follow‐up (Sazbon 1993).
In the early 1950's researchers at the Institute for the Achievement of Human Potential (I.A.H.P.) proposed the idea that programmes of environmental sensory input, at a frequency, intensity, and duration far greater than those in the usual hospital setting, could enhance the speed and degree of recovery from coma. They stated that "in comatose patients, although the problem is primarily cerebral, there is a condition of environmental deprivation that could lead to widespread impairment of intellectual and perceptual processes accompanied by changes in cerebral electrical activity" (Le Winn 1978). The use of sensory stimulation for coma and vegetative state gained popularity in the western world, despite a lack of scientific evidence (Wood 1991, Zasler 1991, Andrews 1996, Giacino 1997).
The intensity of sensory stimulation treatment proposed by different authors has varied considerably. Ranging from one or two cycles of stimulation daily, of approximately one hour each (Mitchell 1990), to one session of multimodal stimulation and one session of unimodal stimulation a day for 10 minutes each (Wilson 1991), to hourly stimulatory cycles, lasting approximately 15‐20 minutes, for 12‐14 hours per day, six days a week (Doman 1993). Yet another approach has been proposed by Wood, who in 1991, performed a critical analysis of the concept of sensory stimulation (Wood 1991). He outlined that "clinical experience has shown that patients exposed to an undifferentiated bombardment of sensory information lose the ability to process information due to the background noise (habituation)". Wood introduced the 'Sensory Regulation' approach, based on the concept of regulating the way in which stimulations are delivered (i.e. create a quiet environment, regulate the way in which staff communicate with patient, etc.) (Wood 1992).
Owing to the severe impact on the life of many individuals, both those with a brain injury and their relatives, it is urgent to know whether these treatments are more effective than a standard rehabilitation programme in promoting recovery from coma and vegetative state. Moreover, as randomised control trials do not seem to be easily accepted in the rehabilitation community we will discuss potential problem in designing and conducting RCTs in this area.
Objectives
To compare the effectiveness of Intense Multisensory Stimulation (IMS) Programme, Formalised Not‐Intensive Stimulation Programme and Sensory Regulation Programme ,to standard rehabilitation treatments in patients with traumatic or non‐traumatic brain injury.
In particular, we wish to test the following hypotheses:
IMS and Sensory Regulation programmes are more effective than standard rehabilitation treatment in arousing patients from coma.
IMS and Sensory Regulation programmes are more effective than standard rehabilitation treatment in reducing time to recovery from coma.
In addition we will assess the methodological quality of relevant studies to identify their major drawbacks and suggest appropriate directions for future research.
Methods
Criteria for considering studies for this review
Types of studies
All Randomised Controlled Trials (RCT) that compared effectiveness of Intense Multisensory Stimulation (IMS) programme, Formalised Not‐Intensive Stimulation Programme or Sensory Regulation Programmes with a usual rehabilitation treatment. If no RCTs were found we intended to perform an analysis of available controlled studies describing their main design characteristics together with selected aspects of their conduct (i.e. length and completeness of follow‐up, type of end point and method of ascertainment, etc.). Controlled trials with historical controls, case series and case reports without a control group were not eligible for this review.
Types of participants
Patients diagnosed as brain injured with traumatic and non‐traumatic etiology (i.e. anoxic), of any age and gender. Patients are defined in different ways in original studies. For the purpose of this review we accepted two definitions. The first, proposed by the American Congress of Rehabilitation Medicine (ACRM 1995), classified patients in two sub‐categories:
a) Coma: unarousable with absence of sleep/wake cycles on electroencephalogram and loss of the ability of environmental interaction. Major neurobehavioral criteria: the patient's eyes do not open either spontaneously or to external stimulation, the patient does not follow any commands.
b) Vegetative State: loss of the ability to interact with the environment despite the capacity for spontaneous or stimulus‐induced arousal, sleep/wake cycles may be present on EEG and subcortical reflexes are partially or fully preserved. Major neurobehavioral criteria: the patient's eyes open spontaneously or after stimulation; the patient does not follow any commands.
The second classification is based on the Glasgow Coma Scale (GCS) where coma is defined when GSC is equal to, or less than, eight (Teasdale 1974).
Types of interventions
Comparison of
'Intense Multisensory Stimulation Programme' (IMS) ‐ e.g Doman's programme defined as stimulatory cycles lasting approximately 15 ‐ 20 minutes, repeated every hour for 12‐14 hours per day, six days a week
'Formalised Not‐Intensive Stimulation Programme' ‐ e.g. Mitchell and Wilson's programme, defined as cycles of stimulation 10‐60 minutes twice a day
'Sensory Regulation Programme' ‐ e.g. 'Wood programme' defined as single brief sessions of stimulation in a quiet environment completely free of noise
Versus
Standard rehabilitation treatment, aimed at reducing behavioural, cognitive and motor complications, with usual nursing interventions, swallowing treatment, nutrition, hydration, physical therapy, and neuro‐pharmachological interventions.
Types of outcome measures
Duration of unconsciousness (including coma and vegetative state) defined as the time between trauma and objective recovery of the ability to respond to verbal commands.
Level of consciousness, as measured by the Glasgow Coma Scale (GCS).
Level of Cognitive Functioning (LCF) (Hagen 1979).
Functional outcomes, as measured by Glasgow Outcome Scale (GOS) (Jennett 1975) or by Disability Rating Scale (Rappaport 1982).
Adverse effects i.e. increased intracranial pressure.
Search methods for identification of studies
Electronic searches
Studies were identified by searching:
the Cochrane Injuries Group's specialised register
the Cochrane Controlled Trial register
MEDLINE
EMBASE
CINAHL
PSYCHLIT (1966‐January 2002).
The search strategy can be found in Appendix 1.
Searching other resources
In addition we scanned the reference lists of relevant articles and contacted experts in the area for further relevant studies that they may have been aware of. We did not apply any language restriction.
Data collection and analysis
Selection of studies
To identify relevant studies abstracts were screened by one reviewer (FL). Studies for inclusion were then independently selected by three reviewers (FL, ADT, MT) and disagreement resolved by consensus. For studies that met the inclusion criteria data was independently extracted by three reviewers using a pre‐specified data extraction sheet. Information extracted included types of patients and interventions, outcomes measured and timing of assessments, method of randomisation, selection criteria for patients, number of patients lost to follow‐up and blinding of outcome assessors. We relied on what was reported in the paper and did not seek additional information from the authors.
Assessment of risk of bias in included studies
Since there is evidence that the quality of allocation concealment particularly affects the results of studies (Schulz 1995), two reviewers scored this quality on the scale used by Schulz (Schulz 1995) as shown below, assigning C to poorest quality and A to best quality:
A=trials deemed to have taken adequate measures to conceal allocation (i.e. central randomization; numbered or coded bottles or containers; drugs prepared by the pharmacy; serially numbered, opaque, sealed envelopes; or other description that contained elements convincing of concealment).
B=trials in which the authors either did not report an allocation concealment approach at all or reported an approach that did not fall into one of the other categories.
C=trials in which concealment was inadequate (such as alternation or reference to case record numbers or to dates of birth).
We compared the scores allocated and resolved differences by discussion.
Results
Description of studies
The searching identified 25 potential studies. Of these, three studies met the inclusion criteria.
The main characteristics of the eligible studies are reported in the table of included studies.
Johnson 1993 This was a randomised controlled trial including 14 male coma patients with GCS equal to or less than eight who suffered acute brain injury due to a road traffic accident and were admitted within 24 hours to an Intensive Care Unit. Patients were randomly assigned into two groups. Seven patients (mean age 27.7, mean GCS 4.8) were allocated to the active intervention group who underwent therapeutic sessions where all five senses (olfactory, visual, auditory, gustatory, tactile) were vigorously stimulated. The sessions lasted 20 minutes a day throughout the patients stay in ICU. The other seven patients (mean age 31.4, mean GCS 4.8) in the control group, received usual care without any specified sensory stimulation programme. The outcome measures, which were assessed daily, were GCS, state of ventilation, spontaneous eye movements, oculocephalic response and oculovestibular response. Skin conductance, heart rate and blood test were assessed 20 minutes before and after treatment.
Kater 1989 This was a controlled clinical trial (CCT) with 30 head injured patients at least two weeks after the trauma. There were 18 male and 12 female participants, (mean age 28 years) with GCS ranging from three to 14 and length of coma ranging from six hours to six months. The study compared a multisensory stimulation programme with usual rehabilitation. The two groups (active intervention and usual rehabilitation), with 15 patients each, were matched for age, sex, type of injury, GCS and length of time from injury each selected from two different health care facilities. Within the two groups, patients were further classified into three subgroups on the basis of GCS score: Deep (GCS 3‐6), Moderate (7‐10) and Light (11‐14). The experimental treatment consisted of a section of stimulation of six modalities: visual, auditory, olfactory, cutaneous, kinestesic and oral, that lasted 45 minutes, twice a day, six days per week until the patients were aroused from coma. Maximum duration of treatment was three months. The outcome measure assessed was 'Level of Cognitive Functioning' (LCF) at two weeks and six months after injury.
Mitchell 1990 The third study was a CCT comparing a coma arousal procedure (CAP) in 12 patients with severe head injury with a matched group of 12 participants receiving usual rehabilitation. The two groups were comparable in terms of demographic characteristics, type and location of head injury, surgical intervention and GCS on admission to hospital. The trial began when patients reached clinical stability (mean 7.9 days). The active intervention group underwent a 'cycle' of sensory stimulation: auditory, tactile, olfactory, taste, visual and kinestesic (60 minutes), one or two times a day, for six days a week, for a maximum of four weeks. Outcomes assessed in this study were GCS score, recorded weekly for four weeks, and total duration of coma.
Risk of bias in included studies
The one randomised controlled trial found (Johnson 1993) did not report details of the method of allocation concealment used. For the two controlled clinical trials (CCTs) (Kater 1989, Mitchell 1990) important details of the methods used to select the groups, (i.e. were patients truly consecutive? Did referral criteria differ from one ward to another? etc.), were not reported. None of the three studies used blinding for outcome assessment. All the studies included all patients originally recruited in the final analysis although for the two CCTs this is more difficult to assess given the nature of the study design. As far as the appropriateness of the outcome measures used is concerned, two studies used the GCS only without any other indicator of functional status. The study by Kater (Kater 1989) used the LCF scale but analysed results inappropriately considering it a continuous variable rather than a descriptive‐nominal one. Only one study presented a functional assessment at a fairly long follow‐up (three months). Studies recruited very few patients (range 14‐30).
Effects of interventions
As only one study was randomised and studies differed widely in terms of outcomes measured, as well other important aspects of study design and conduct, we did not carry out any quantitative synthesis of data.
Overall none of the three studies provided useful and valid results on outcomes of clinical relevance for coma patients. Johnson (Johnson 1993) did not report information on the main outcome measure (GCS) and only presented data of questionable clinical relevance (i.e. heart rate, skin conductance, cathecholamine, 3‐methoxy,4‐hydroxyphenylglicol.). The statistical analysis of data in one of the studies (Kater 1989) was flawed because the LCF scale was analysed as a continuous rather than as a qualitative variable. Therefore, the statistically significant difference in favour of the actively treated group reported in the study must be interpreted with caution. Finally, the study by Mitchell (Mitchell 1990) reported a significant difference in the mean length of coma in favour of the experimental group (22 days ‐ SD 9.7 versus 26.9 days ‐ SD 6.6 ‐ control group, p<0,05). However, the clinical relevance of this outcome measure, divorced from any other functional indicator, is questionable.
Discussion
a) Quality and reliability of available studies
We found three studies meeting our inclusion criteria of which only one was a randomised controlled trial. Overall, this review does not provide enough information to allow us to make any conclusions about the effect of sensory stimulation in coma patients. Considering the health care, social and emotional implications that the treatment of coma and vegetative state patients has for patients, family and their carers, the dearth of reliable data and poor quality of the studies is astonishing. Although this review does not support or rule out the effectiveness of this intervention, we still believe that this critical appraisal may provide useful insight for further studies in this area.
One of the major methodological drawbacks in the studies reviewed is the inconsistent use of definitions of coma and vegetative state. This led to important inter‐study variation of the criteria used to assess arousal from coma. In the Kater study, for example, patients with GSC values in the 10‐14 range have also been included and this raises important questions about the comparability of the results of this study with others. This, together with the unblinded evaluation of the patient status could lead to important biases. Methodological rigor is also lacking in the definition of the experimental intervention (ie. sensory stimulations). In the Kater study, for example, relatives were asked to deliver stimuli but no information was presented on how they were trained, what they did in practice and whether this was done in addition to the stimulation delivered by therapists during sessions or instead of it. Also relatives were asked to assess patient's reactions to the intervention but again without any information on how this was done and how it was used in the analysis. In the Mitchell study sessions lasted 45 minutes but the study reports that one or two sessions could be delivered without giving details of what criterion, if any, was used to decide on the intensity of treatment.
Two of the three studies included in this review used outcomes of questionable clinical relevance. In the studies we reviewed the use of functional outcomes that could add important clinically relevant information was extremely rare. Johnson used only physiological/biochemical markers and Mitchell measured the length of coma alone without looking at whether this was associated with a lower score on any disability measure. It is unfortunate that the study by Kater, the only one that used a functional outcome (Levels of Cognitive function, LCF), used inappropriate statistical analysis that meant the results could not be interpreted reliably.
b) Is the dearth of rigorous studies justifiable?
Randomised controlled trials are still rarely used in this setting and their suitability to evaluate interventions in rehabilitation have been debated (Whyte 1994). In the case of the intervention considered in this review, however, we do not think there are good reasons why randomised controlled trials cannot be conducted. As sensory stimulation represents an intervention that is additional to standard care it is hard to see why patients could not be randomised. Furthermore, as potential bias in outcome assessment may occur it is important to overcome this by having independent assessment of the impact of sensory stimulation on patients. Reservations about the feasibility of conducting RCTs may also arise from the idea that providers' skills in delivering stimuli may bias the results. This may be true but the same objection may be made in many other clinical situations (i.e. surgery, psychosocial interventions etc) where RCTs have been carried out. It is true, however, that an important limitation to the conduct of reliable studies in this area is the lack of sufficiently sensitive and valid tools for outcome assessment.
Authors' conclusions
Implications for practice.
This systematic review indicates that there is no reliable evidence to support, or rule out, the effectiveness of multisensory programmes in patients in a coma or vegetative state.
The need to improve our current knowledge in this field, as well as the dearth of effective treatments in this area, strongly indicates that the delivery of treatment interventions based on the concept of 'sensory stimulation' should be provided only in the context of properly designed and adequately sized randomised controlled trials.
Implications for research.
Future studies in this area are needed. As almost 50% of patients have a spontaneous arousal after the acute event, and because of the difficulty of delivering rehabilitation programmes in the intensive care setting (Grosswasser 1990) where patients are often sedated and assessment are usually made on physiological measurments, studies should recruit patients in a stable clinical condition who are discharged from intensive care units. The size of the studies should be sufficient to detect a clinically relevant difference between study groups. To recruit sufficient numbers of patients it may be necessary to organise multi‐centre randomised controlled trials. Outcomes measured should be both related to the impairment but also to functional abilities. The latter should be evaluated at least at an interval of six to 12 months in order to evaluate the consistency of the findings overtime. Due to the potential for bias due to subjectivity and expectations from carers, outcomes should be subject to a rigorous blinded assessment.
What's new
| Date | Event | Description |
|---|---|---|
| 11 September 2008 | Amended | Converted to new review format. |
Acknowledgements
We thank Frances Bunn and Reinhard Wentz from the Injuries Group for their help in conducting the search for studies. We also thank Paolo Boldini, Anna Mazzucchi and Claudio Perino for their contribution in the preparation of the protocol of this review.
Appendices
Appendix 1. Search strategy
The following terms were used (MeSH headings in capital letters):
BRAIN INJURIES OR HEAD INJURIES OR Brain NEAR injur* OR Head NEAR injur* and COMA OR COMA, POST HEAD INJURY OR PERSISTENT VEGETATIVE STATE OR UNCONSCIOUSNESS OR Comatos* OR vegetat* OR unconscious* and REHABILITATION OR Rehabilitat* OR Enrich* OR depriv* OR Sensor* OR stimulat*
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Johnson 1993.
| Methods | Randomised controlled trial. Randomisation method: not specified. | |
| Participants | 14 caucasian male adults, affected by traumatic brain injury from road traffic accident, with GCS < = 8, consecutively admitted within 24 hours to the intensive care unit. Experimental group: 7 subjects, mean age 27.7 (12.3), mean GCS: 4.8 (1.9) Control group : 7 subjects, mean age 31.4 (11.2) mean GCS: 4.8 (1.4) Patients with neurological or psychiatric disorders, alcohol or drug abuse, or previous head injuries were excluded. | |
| Interventions | Experimental group: stimulation of five senses for 20‐minute a day for all their stay in the ICU (median stay 8.1 days). Order of stimulus presentation was randomized. Control group were not stimulated during the same period (stay medium 3.7 days). | |
| Outcomes | Glasgow Coma Scale (GCS), State of ventilation, Spontaneous eye movements, Oculocephalic response, Oculovestibular response, assessed daily. Catecholamine levels, Serotonin level, Acetylcholinesterase level, 3‐methoxy,4‐hydroxyphenylglicol, skin conductance, heart rate, assessed 20 minutes pre‐ and post‐treatment period. | |
| Notes | Randomisation method not specified. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |
Kater 1989.
| Methods | Controlled clinical trial. Two groups were matched for age, sex and type of injury ‐ each selected for two different health care facilities. | |
| Participants | 30 patients with traumatic brain injury (mean age 28 y, range 18‐47, 18 male and 12 female), at least 2 weeks from the trauma, admitted at 2 different health care facilities. GCS ranged from 3 to 14, length of coma ranged from 6 hours to 6 months. The subjects in the control group (15) were matched with the patients in the experimental group (15) on the basis of age, sex, type of injury, GCS and length of time post‐injury. | |
| Interventions | Experimental group: stimulation of 6 modalities: visual, auditory, olfactory, cutaneous, kinestesic, oral. Treatment initiated at least 2 weeks from the trauma, and lasted 45 minutes, twice a day, 6 days per week for a 1 to 3 month period, depending of the subject’s length of coma. Relatives were encouraged to apply sensory stimulation whenever they approached or delivered care to the patient. Control group received nursing care without planned, structured sensory stimulation. | |
| Outcomes | Level of Cognitive Functioning (LCF) measured 2 weeks post injury (baseline) and at 3 months post injury. | |
| Notes | In this study the inclusion criteria were broad (e.g. GCS from 3 to 14). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | High risk | C ‐ Inadequate |
Mitchell 1990.
| Methods | Controlled clinical trial. The two groups were matched on demographic characteristics, type and location of head injury, surgical intervention and GCS on admission to hospital. | |
| Participants | 24 patients with traumatic brain injury divided in 2 groups of 12 patients, treated in the same Neurological Unit. Treatment group: 10 male and 2 female, mean age 22.3 (6.15), range 17‐40; range GCS admission 4‐6. Control group : 10 male and 12 female, mean age 22.75 (6.77), range 17‐42; range GCS admission 4‐6. The two groups were matched on the basis of age, sex, type and location of head injury, surgical intervention and GCS on admission to hospital. | |
| Interventions | Experimental group: visual, auditory, olfactory, tactile, gustatory, kinestetic and vestibular stimulation. The stimulation sessions started from 4 to 12 days following injury (mean 7.08 days). Treatment lasted 1 hour for 1or 2 times a day. Control group did not receive arousal procedure at any time while in coma. | |
| Outcomes | Total duration of coma (days). Glasgow Coma Scale (GCS). | |
| Notes | Timing of GCS not specified. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | High risk | C ‐ Inadequate |
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
|---|---|
| Boyle 1983 | Case series. |
| Cooper 1999 | CCT with historical control group and with intervention based on a single stimulation, not multisensory. |
| De Young 1987 | Case series. |
| Doman 1993 | Case series. |
| Guina 1997 | Single case trial. |
| Hall 1992 | Case series. |
| Johnson 1989 | Case series. |
| Jones 1994 | Single case trial. |
| Le Winn 1978 | CCT with historical control group. |
| Mackay 1992 | CCT, the experiemental group underwent other interventions and not only multisensory stimulation. |
| Pierce 1990 | Case series. |
| Rader 1989 | Case series. |
| Rosadini 1982 | Case series. |
| Schinner 1995 | Case series. |
| Sisson 1990 | Case series. |
| Weber 1984 | Case series. |
| Wilson 1991 | Case series. |
| Wilson 1993 | Case series. |
| Wilson 1996 A | Case series. |
| Wilson 1996 B | Case series. |
| Wood 1992 | CCT with historical control group. |
| Wood 1993 | CCT with historical control group. |
Contributions of authors
Lombardi F: Helped to design the protocol, read the original studies, assessed study quality, helped with the interpretation of results and drafted the initial version of the manuscript. Taricco M: Helped to design the protocol, read the original studies, assessed study quality, provided methodological guidance during the conduct of the review, helped with the interpretation of results, drafted the initial manuscript and reviewed the final version. De Tanti A : Helped to design the protocol, read the original studies, assessed study quality, helped with the interpretation of results and drafted the initial version of the manuscript. Telaro E : Helped with the preparation of the study protocol, provided methodological guidance during the entire review process and commented on earlier and final versions of the manuscript. Liberati A : Helped with the preparation of the study protocol, assisted with the preparation of the manuscript, contributed to the interpretation of the results, reviewed and edited its final version.
Sources of support
Internal sources
Ospedale di Correggio, Italy.
External sources
No sources of support supplied
Declarations of interest
None known.
Edited (no change to conclusions)
References
References to studies included in this review
Johnson 1993 {published data only}
- Johnson DA, Roething‐Johnston K, Richards D. Biochemical and physiological parameters of recovery in acute severe head injury. Brain Injury 1993;7(6):491‐9. [DOI] [PubMed] [Google Scholar]
Kater 1989 {published data only}
- Kater KM. Response of head‐injured patients to sensory stimulation. Western Journal of Nursing Research 1989;11(1):20‐33. [DOI] [PubMed] [Google Scholar]
Mitchell 1990 {published data only}
- Mitchell S, Bradley VA, Welch JL, Britton PG. Coma arousal procedure: a therapeutic intervention in the treatment of head injury. Brain Injury 1990;4(3):273‐9. [DOI] [PubMed] [Google Scholar]
References to studies excluded from this review
Boyle 1983 {published data only}
- Boyle MEM, Greer RD. Operant procedures and the comatose patient. Journal of Applied Behaviour Analysis 1983;16:3‐12. [DOI] [PMC free article] [PubMed] [Google Scholar]
Cooper 1999 {published data only}
- Cooper JB, Jane JA, Alves WM, Cooper EB. Right median nerve electrical stimulation to hasten awakening from coma. Brain‐Injury 1999;13(4):261‐7. [DOI] [PubMed] [Google Scholar]
De Young 1987 {published data only}
- Young S, Grass RB. Coma recovery program. Rehabilitation Nursing 1987;12(3):121‐4. [DOI] [PubMed] [Google Scholar]
Doman 1993 {published data only}
- Doman G, Wilkinson R, Dimancescu MD, Pelligra R. The effect of intense multisensory stimulation on coma arousal and recovery. Neuropsychological Rehabilitation 1993;3(2):203‐12. [Google Scholar]
Guina 1997 {published data only}
- Guina FD, Cosic T, Kracun L, Dimic Z. Sensorimotor stimulation of comatose patients. Acta Medica Croatica 1997;51:101‐3. [PubMed] [Google Scholar]
Hall 1992 {published data only}
- Hall MEM, MacDonald S, Young GC. The effectiveness of directed multisensory stimulation versus non‐directed stimulation in comatose CHI patients: pilot study of a single subject design. Brain Injury 1992;6(5):435‐45. [DOI] [PubMed] [Google Scholar]
Johnson 1989 {published data only}
- Johnson MJ, Omery A, Nikas D. Effects of conversation on intracranial pressure in comatose patients. Heart Lung 1989;18:56‐63. [PubMed] [Google Scholar]
Jones 1994 {published data only}
- Jones R, Hux K, Morton‐Anderson A, Knepper L. Auditory stimulation effect on a comatose survivor of traumatic brain injury. Arch Phys Med Rehabil 1994;75:164‐71. [PubMed] [Google Scholar]
Le Winn 1978 {published data only}
- Winn EB, Dimancescu MD. Environmental deprivation and enrichment in coma. Lancet 1978;2(8081):156‐7. [DOI] [PubMed] [Google Scholar]
Mackay 1992 {published data only}
- Mackay LE, Bernstein BA, Chapman PE, Morgan AS, Milazzo LS. Early intervantion in severe head injury: long‐term benefits of a formalized program. Arch Phys Med Rehabil 1992;73:635‐41. [PubMed] [Google Scholar]
Pierce 1990 {published data only}
- Pierce JP, Lyle DM, Quine S, Evans NJ, Morris J, Fearnside MR. The effectiveness of coma arousal intervention. Brain Injury 1990;4(2):191‐7. [DOI] [PubMed] [Google Scholar]
Rader 1989 {published data only}
- Rader MA, Alston JB, Ellis DW. Sensory stimulation of severely brain‐injured patients. Brain Injury 1989;3(2):141‐7. [DOI] [PubMed] [Google Scholar]
Rosadini 1982 {published data only}
- Rosadini G, Sannita WG. Inter‐ and intra‐hemispheric topographic analyses of quantitative EEG in patients in coma. Research Communications in Psychology, Psychiatry and Behaviour 1982;7(1):97‐107. [Google Scholar]
Schinner 1995 {published data only}
- Schinner KM, Chisolm AH, Grap MJ, Siva P, Hallinan M, LaVoice‐Hawkins AM. Effects of auditory stimuli on intracranial pressure and cerebral perfusion pressure in traumatic brain injury. Journal of Neuroscience Nursing 1995;27(6):348‐54. [DOI] [PubMed] [Google Scholar]
Sisson 1990 {published data only}
- Sisson R. Effects of auditory stimuli on comatose patients with head injury. Heart Lung 1990;19:373‐8. [PubMed] [Google Scholar]
Weber 1984 {published data only}
- Weber PL. Sensorimotor therapy: its effect on electroencephalograms of acute comatose patients. Archives of Physical Medicine and Rehabilitation 1984;65:457‐62. [PubMed] [Google Scholar]
Wilson 1991 {published data only}
- Wilson SL, Powell GE, Elliot K, Thwaites H. Sensory stimulation in prolonged coma: four single case studies. Brain Injury 1991;5(4):393‐400. [DOI] [PubMed] [Google Scholar]
Wilson 1993 {published data only}
- Wilson SL, Powell GE, Elliot K, Thwaites H. Evaluation of sensory stimulation as a treatment for prolonged coma ‐ seven single experiemental case studies. Neuropsychological Rehabilitation 1993;3(2):191‐201. [Google Scholar]
Wilson 1996 A {published data only}
- Wilson SL, Powell GE, Thwaites H, Elliot K. Constructing arousal profiles for vegetative state patients ‐ a preliminary report. Brain Injury 1996;10(2):105‐13. [DOI] [PubMed] [Google Scholar]
Wilson 1996 B {published data only}
- Wilson SL, Powell GE, Rock D, Thwaites H. Behavioural differnces between patients who emerged from vegetative state and those who did not. Brain Injury 1996;10(7):509‐16. [DOI] [PubMed] [Google Scholar]
Wood 1992 {published data only}
- Wood R, Winkowski TB, Miller JL, Tierney L, Goldman L. Evaluating sensory regulation as a method to improve awareness in patients with altered states of consciousness: a pilot study. Brain Injury 1992;6(5):411‐8. [DOI] [PubMed] [Google Scholar]
Wood 1993 {published data only}
- Wood RL, Winkowski T, Miller J. Sensory regulation as a method to promote recovery in patients with altered states of consciousness. Neuropsychological Rehabilitation 1993;3(2):177‐90. [Google Scholar]
Additional references
ACRM 1995
- American Congress of Rehabilitation Medicine. Recommendations for use of uniform nomenclature pertinent to patients with severe alterations in consciousness. Arch Phys Med Rehabil 1995;76:205‐9. [DOI] [PubMed] [Google Scholar]
Andrews 1996
- Andrews K. International working party on the management of the vegetative state: summary report. Brain Injury 1996;11:797‐806. [DOI] [PubMed] [Google Scholar]
Giacino 1997
- Giacino JT, Zasler ND, Katz DI, Kelly JP, Rosenburg JH, Filley CM. Development of practice guidelines for assessment and management of the vegetative and minimally conscious states. J Head Trauma Rehab 1997;12:79‐89. [Google Scholar]
Grosswasser 1990
- Grosswasser Z, Sazbon L. Outcome in 134 patients with prolonged post‐traumatic unawareness. J Neurosurg 1990;72:81‐4. [DOI] [PubMed] [Google Scholar]
Hagen 1979
- Downey. Levels of Cognitive Functioning. In: Hagen C, Malkmus D, Durham P editor(s). Rehabilitation of the head injured adult. Comprehensive physical management. Professional Staff Association of Rancho Los Amigos Hospital, Inc. 1979. [Google Scholar]
Jennett 1975
- Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet 1975;1:480‐4. [DOI] [PubMed] [Google Scholar]
Jennett 1982
- Jennet B, Bond M. Disability Rating Scale for severe head trauma: coma to community. Archives of Physical Medicine and Rehabilitation 1982;63(3):118‐123. [PubMed] [Google Scholar]
Le Winn 1978
- Winn EB, Dimancescu MD. Environmental deprivation and enrichment in coma. Lancet 1978;2(8081):156‐7. [DOI] [PubMed] [Google Scholar]
Levin 1991
- Levin HS, Saydjari C, Eisenberg HM, Foulkes M, et al. Vegetative State after closed head injury: A traumatic coma data bank report. Archives of Neurology 1991;48:580‐5. [DOI] [PubMed] [Google Scholar]
Moher 1995
- Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Controlled Clinical Trials 1995;16:62‐73. [DOI] [PubMed] [Google Scholar]
Rappaport 1982
- Rappaport M, Hall KM, Hopkins HK, Belleza T, Cope DN. Disability rating scale for severe head trauma: coma to community. Archives of Physical Medicine and Rehabilitation 1982;63(3):118‐23. [PubMed] [Google Scholar]
Sazbon 1993
- Sazbon L, Zagreba F, Ronen J, Solzi P, Costeff H. Course and outcome of patients in vegetative state of nontraumatic aetiology. Journal of Neurology, Neurosurgery and Psychiatry, 1993;56:407‐9. [DOI] [PMC free article] [PubMed] [Google Scholar]
Schulz 1995
- Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408‐12. [DOI] [PubMed] [Google Scholar]
Task Force on PVS
- The Multi‐society Task Force on PVS. Medical aspects of the Persistent Vegetative State (second of two parts). N Engl J Med 1994;330:1572‐9. [DOI] [PubMed] [Google Scholar]
Teasdale 1974
- Teasdale G, Jennet B. Assessment of coma and impaired consciuosness: A practical scale. The Lancet 1974;2:81‐4. [DOI] [PubMed] [Google Scholar]
Whyte 1994
- Whyte J. Toward a methodology for rehabilitation research. Am J Phys Med Rehabil 1994;6:428‐35. [DOI] [PubMed] [Google Scholar]
Wood 1991
- Wood RL. Critical analysis of the concept of sensory stimulation for patients in vegetative states. Brain Injury 1991;4:401‐10. [DOI] [PubMed] [Google Scholar]
Wood 1992
- Wood R, Winkowski TB, Miller JL, Tierney L, Goldman L. Evaluating sensory regulation as a method to improve awareness in patients with altered states of consciousness: a pilot study. Brain Injury 1992;6:411‐8. [DOI] [PubMed] [Google Scholar]
Zasler 1991
- Zasler ND, Kreutzer JS, Taylor D. Coma stimulation and coma recovery: a critical review. NeuroRehabilitation 1991;1:33‐4. [Google Scholar]