Scherder 1999b.
Methods | Randomised, double‐blind, placebo‐controlled, 6 weeks | |
Participants | Holland Single center Study 1: 8 subjects, 4 expt, 4 control Study 2: 16 subjects, 8 expt, 8 control Study 3: 18 subjects, 9 expt, 9 control Lived in a residential home for elderly people. Meeting NINCDS‐ADRDA criteria for clinical diagnosis of probable demetia of Alzheimers type. Studies 1‐3: early stage of AD (stage 5 of GDS) Study 4: midstage of AD (stage 6 of GDS) Exclusion: history of psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, infection, epilepsy, disturbances of consciousness or focal brain abnormalities. | |
Interventions | Stimulation not described except that Premier 10s stimulator used.
Study 1: TENS for 6 hours/day, therapist present throughout
Study 2: TENS for 30 min/day, therapist present throughout
Study 3: TENS without therapist present (called "isolated TENS" in the report), duration of treatment not indicated.
Study 4: no description of TENS intervention given. Therapist present. All studies: 5 days/week, 6 weeks |
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Outcomes | t‐test
Neuropsycological tests:
Digit span: ns for studies 1 ‐ 4 Visual memory span: ns for study 1, ns study 2, p = 0.002 study 3, p = 0.004 study 4.
8/15 words test (15 word used only in study 1)
Immed. recall: p = 0.03 study 1, ns studies 2‐4
Delayed recall: ns studies 1‐4
Recognition: p = 0.05 studies 1 & 2, ns studies 3 & 4
Face recognition: ns studies 1 & 4, p = 0.01 study 2, p = 0.04 study 3.
Picture recognition: ns studies 1, 3 & 4, p = 0.001 study 2.
Word fluency: p = 0.04 study 1, ns studies 2 & 4, p = 0.03 study 3 Behavioural observational scales: Beoordelingsschaal vor Oudere Patienten (BOP) Subscales Need of help: ns studies 1 & 4, p = 0.01 study 2, p = 0.04 study 3 Aggressiveness: ns Physical invalidity: ns studies 1, 3 & 4, p =0.02 study 2 Depressed behaviour: ns Mental invalidity: ns Inactivity: ns Behaviour inventory: ns studies 1, 3, 4, p = 0.03 study 2. |
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Notes | Poor/limited reporting of interventions and results. Authors imply that treatment effect was evaluated directly post‐treatment and 6 weeks later but only one set of results given. They note that "Analyses of the data obtained after 6 weeks without stimulation revealed that the majority of the treatment effects observed in the above‐mentioned studies disappeared." Consider excluding due to limitations of description of interventions and outcomes. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |