Table 1.
Summary of clinical trials for combination therapy of spinal cord injury
| NCT Number | Status | Conditions | Study Type | Phase | Interventions | Population | Study Design / Primary Purpose | Outcome Measures | Date(Study Start / Last Update) | Locations | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment /Age | Sex | |||||||||||
| NCT00291317 | Completed | Spinal Cord Injury | InterventionalClinical Trial | N/A | Device: RT 300-PFES Cycle |
6 / 4 Years to 21 Years (Child, Adult) | All | Single Group Assignment / Treatment |
Change in Pediatric Quality of Life/ Change in Bone Mineral Density | 2006 / 2012 | United States | |
| NCT01143597 | Completed | Spinal Cord Injury | InterventionalClinical Trial | N/A | Exercise: Arm and hand training |
48/ 16 Years to 70 Years (Child, Adult, Older Adult) | All | RandomizedParallel Assignment / Treatment |
Cortical motorexcitability via transcranial magnetic stimulation (TMS) |
2007 / 2013 | United States | |
| NCT01471613 | Completed | Spinal Cord Injury | InterventionalClinical Trial | I,II | Procedure: Conventional Treatment Drug: Lithium Carbonate Tablet, PlaceboBiological: Cord Blood Cell |
16 / 18 Years to 65 Years (Adult, Older Adult) |
All | Randomized,Parallel Assignment / Treatment |
Change from Baseline in AIS Motor and sensory scores Walking Functional assessment Locomotion Pain | 2011 / 2014 | China | |
| NCT01232907 | Completed | Spinal Cord Injury (SCI) | InterventionalClinical Trial | II | Drug: L-Carnitine |
2 / 19 Years to 65 Years (Adult, Older Adult) |
All | Randomized,Single Group Assignment / Treatment |
Fatigue, Pain, Depression will be completed by subjects biweekly | 2010 / 2014 | Canada | |
| NCT02098135 | Completed | -Stroke -Spinal Cord Injury |
InterventionalClinical Trial | N/A | Device: ArmeoSenso |
14 / 18 Years and older (Adult, Older Adult) | All | Single Group Assignment / Treatment |
Training Improvement in the Arm function | 2013 / 2015 | Switzerland | |
| NCT01484184 | Completed | Spinal Cord Injury | InterventionalClinical Trial | I, II | Drug: SPINALON (buspirone + levodopa + cardidopa) |
50/ 18 Years to 65 Years (Adult, Older Adult) | All | Randomized, Factorial Assignment /Treatment | Pharmacokinetics Blood pressure Respiration rate Oxygen saturation Change in hematology and biochemistry laboratory Parameters Occurrence of rhythmic leg EMGs | 2013 / 2015 | Canada | |
| NCT00634426 | Completed | - Metastatic Epidural - Spinal Cord Compression |
Observational | Procedure: Surgical excision of the metastatic processRadiation: Radiotherapy of the metastatic spine process |
163 / 18 Years and older (Adult, Older Adult) |
All | CohortProspective | Change in spineassociated pain intensity Neurological outcomes Survival Adverse events | 2008 / 2015 | United States, Canada | ||
| NCT01621113 | Completed | Spinal Cord Injury | InterventionalClinical Trial | II | Drug: Dalfampridine, Placebo |
27 / 18 Years to 70 Years (Adult, Older Adult) |
All | Randomized,Parallel Assignment / Treatment |
Change in Walk Test Change in Spinal Cord Injury Functional Ambulation Index (SCI-FAI) Change in Lower-Extremity Motor Scores | 2012 / 2017 | United States | |
| NCT01435798 | Completed | -Central Neuropathic Pain- Allodynia- Spinal Cord Injury |
InterventionalClinical Trial | II | Drug: Dextromethorphan |
26 / 18 Years to 70 Years (Adult, Older Adult) |
All | Randomized,Crossover Assignment /Treatment | Mean Pain Intensity (Percent Change From Baseline) Satisfaction | 2003 / 2017 | United States | |
| NCT02218203 | Completed | -Central Neuropathic Pain- Allodynia- Spinal Cord Injury |
InterventionalClinical Trial | II | Drug: DextromethorphanDrug: LidocaineDrug: Placebo (Dextromethorphan)Drug: Placebo (Lidocaine) |
26 / 18 Years to 70 Years (Adult, Older Adult) |
All | Randomized,Factorial Assignment /Treatment | Percent Change in Peak Pain Intensity | 2003 / 2018 | United States | |
| NCT01225055 | Completed | - Spinal Cord Injury- Bone Loss-Osteoporosis | InterventionalClinical Trial | II | Drug: Teriparatide Device: Vibration |
60 / 21 Years and older (Adult, Older Adult) | All | Randomized,Parallel Assignment / Treatment |
Bone Mineral Density (Hip, Lumbar Spine, Femoral Neck)C-terminal Telopeptide Bone-specific Alkaline PhosphataseAmino-terminal Propeptide of Type Collagen | 2010 / 2018 | United States | |
| Table 1. Continued | ||||||||||||
| NCT03112941 | Completed | Spinal Cord Injuries | InterventionalClinical Trial | N/A | Procedure: Control groupOther: hyperbaric oxygen group |
164 / 18 Years and older (Adult, Older Adult) | All | Randomized,Parallel Assignment / Treatment |
Modified Barthel index American Spinal Injury Association impairment scale grading | 2012 / 2018 | ||
| NCT01621984 | Completed | Neuromuscular Disease |
InterventionalClinical Trial | I | Other: Therapeutic Riding/ Hippotherapy Intervention |
60 / 4 Years to 18 Years(Child, Adult) |
All | Single Group Assignment /Treatment | Improvement in Gross Motor Function and PerformanceDecrease of spasticity Improvement in Quality of life | 2012 / 2018 | Greece | |
| NCT03810963 | Completed | Spinal Cord Injuries | InterventionalClinical Trial | N/A | Combination Product: HIIT-FES Cycling combined with Nutritional CounselingOther: Nutritional Counseling Only |
15 / 21 Years to 65 Years(Adult, Older Adult) |
All | Non- Randomized,Parallel Assignment / Treatment |
Body Fat Percentage Arterial health via flow mediated dilation Blood glucose testing Pre- post- intervention three day dietary recall | 2017 / 2019 | United States | |
| NCT03457714 | Completed | - Spinal Cord Injuries- Depression- Anxiety | Observational | Behavioral: Guided ICBT for persons with Spinal Cord InjuryOther: Survey |
20 / 18 Years and older (Adult, Older Adult) | All | Cohort Prospective |
Change in depression Change in anxiety Pain interference Quality of life | 2017 / 2019 | Canada | ||
| NCT04034108 | Completed | Spinal Cord Injuries | InterventionalClinical Trial | N/A | Procedure: Surgical intervention combined with weight-supported ambulation training |
339 / 4 Years to 76 Years(Child, Adult, Older Adult) |
All | Single Group Assignment /Treatment | Change of Kunming Locomotor Scale (KLS) Change of American Spinal Injury Association Impairment Scale (AIS) Magnetic Resonance Imaging | 2000 / 2019 | China | |
| NCT02495545 | Completed | Spinal Cord Injury | InterventionalClinical Trial | N/A | Procedure: CSFD and elevation of MAPProcedure: Maintenance of MAP |
15 / 18 Years to 75 Years(Adult, Older Adult) |
All | Randomized,Parallel Assignment /Treatment |
Change in ISNCSCI Motor Score ISNCSCI Sensory ScoresISNCSCI Upper & Lower Extremity Motor Score Spinal Cord Independence Measure Pain level per patient report | 2015 / 2019 | United States | |
| NCT04624607 | Completed | - Spinal Cord Injuries- Paraplegia, Spinal- Tetraplegia/ Tetraparesis | InterventionalClinical Trial | N/A | Device: Transspinal transcortical paired-associative stimiulation combined with robotic gait training |
14 / 18 Years to 70 Years(Adult, Older Adult) |
All | Randomized,Crossover Assignment / Treatment | Plasticity of cortical and corticospinal neural circuits Plasticity of spinal neural circuits Sensorimotor leg motor function Walking function |
2018 / 2020 | United States | |
| NCT04566809 | Completed | Spinal Cord Injury at C5-C7 Level | InterventionalClinical Trial | N/A | Other: FES+CBA |
16 / 18 Years to 75 Years(Adult, Older Adult) |
All | Randomized,Crossover Assignment /Health Services Research |
Performance test: Bimanual Ability Test Spinal Cord Independence Measure (SCIM) Grasping Strength (GS) | 2016 / 2020 | Italy | |
| NCT03690726 | Completed |
- Spinal Cord Injury- Rehabilitation- Transcranial Magnetic Stimulation-Neurorehabilitation |
InterventionalClinical Trial | N/A | Device: Repetitive transcranial magnetic stimulationOther: Sham stimulation |
19 / 18 Years to 80 Years(Adult, Older Adult) |
All | Randomized,Parallel Assignment /Treatment |
Walking test Lower limb maximal muscle strength Timed up and go test Quantitative Sensory Testing Pressure algometry Self-reported pain |
2019 / 2020 | Denmark | |
| Table 1. Continued | ||||||||||||
| NCT03179475 | Completed | Chronic Pain | InterventionalClinical Trial | IV | Drug: Oxycodone Naloxone Combination |
1 / 18 Years to 65 Years(Adult, Older Adult) |
Single Group Assignment /Treatment | Change in management of pain related to SCI Change from Baseline of autonomic function Change from Baseline of quality of life.Change from Baseline in depressive symptoms Change from baseline of opioid side effects | 2019 / 2021 | Canada | ||
| NCT04670406 | Completed |
- Spinal Cord Injuries- Psychological Distress |
InterventionalClinical Trial | N/A | Behavioral: acceptance and commitment therapy (ACT) combined with psychoeducation |
10 / 18 Years and older(Adult, Older Adult) | All | Single Group Assignment /Treatment | Engagement in Meaningful Activities Survey Action and Acceptance Questionnaire(SCI-QOL) Resilience Short form Mindful Attention Awareness Scale |
2021 / 2021 | United States | |
| NCT04790149 | Completed | Spinal Cord Injuries | InterventionalClinical Trial | N/A | Other: Conventional RehabilitationOther: NEUROM |
56 / 25 Years to 40 Years (Adult) |
All | Randomized,Parallel Assignment /Treatment |
ASIA Vividness of motor imagery questionnaire (VMIQ) Assessment of movement attempt and execution | 2017 / 2021 | Lebanon | |
| NCT02830074 | Completed |
- Spinal Cord Injury- Sleep-disordered Breathing- Spinal Cord Disease- Multiple Sclerosis |
InterventionalClinical Trial | N/A | Behavioral: Best practices PAP + patient Education +ongoing Support and TrainingBehavioral: Sleep Education |
73 / 18 Years and older(Adult, Older Adult) | All | Randomized,Parallel Assignment /Treatment |
Subjective Sleep Quality Was Measured by The (PSQI) Quality of Life Respiratory Function Depressive Symptom Severity Fatigue Symptoms |
2017 / 2021 | United States | |
| NCT04697472 | Completed | Chronic Spinal Cord Injury |
InterventionalClinical Trial | N/A | Device: LIFT System |
65 / 22 Years to 75 Years(Adult, Older Adult) |
All | Sequential Assignment /Treatment | Incidence of serious adverse events (SAEs) Change in upper extremity strength and function Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone |
2021 / 2022 | United States Canada |
|
| NCT04171375 | Completed | - Spinal Cord Injuries- Stroke- Paralysis | InterventionalClinical Trial | N/A | Device: Transspinal Electrical Stimulation (tsES) |
2 / 19 Years to 55 Years (Adult) |
All | Single Group Assignment /Treatment | ASIA Impairment ScaleNeuromuscular Recovery Scale Spinal Cord Independence Measure Walking test |
2019 / 2022 | Hong Kong | |
| NCT03240601 | Completed | -Transcutaneous Spinal Stimulation- Walking- Spasticity- Spinal Cord Injuries | InterventionalClinical Trial | N/A | Device: Transcutaneous spinal stimulation |
18 / 18 Years to Years(Adult, Older Adult) |
All | Randomized,Parallel Assignment / Treatment |
Change in Walking FunctionChange in Spasticity -MuscleChange in Spasticity - Spinal Cord Assessment Stimulation Tolerability |
2017 / 2022 | United States | |
N/A: Not Applicable; Interventional (Clinical Trial); SCI: spinal cord injury; International Standards for Classification of Spinal Cord Injury Motor Score (ISNCSCI, formerly ASIA) Spinal Cord Injury-Quality of Life (SCI-QOL); ASIA: American Spinal Injury Association Scale; PSQI: Pittsburgh Sleep Quality Index