Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke

Study Overview
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Brief Summary
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Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome. We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans. This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.

Official Title
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Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study

Conditions
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First Ever Clinical Stroke, Ischemic Stroke, Subacute Phase, Persistent Hemiparesis of Upper Extremity

Intervention / Treatment
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* Procedure: transcranial direct current stimulation (tDCS)
* Procedure: Sham stimulation, then tDCS
* Procedure: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke Persistent hemiparesis, indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) (Brott et al. 1989) but wrist and finger movement is not required No UE injury or conditions that limited use prior to the stroke. The patient is >18 years old. The patient has subscribed the informed consent Exclusion Criteria: History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones) Severe pain in the affected upper limb (>=8 on the shoulder item of the joint pain during passive motion of the Fugl-Meyer Assessment Upper Extremity) Further stroke or other significant medical complication during the study Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale) Important aphasia that would impair the understanding and performance of the assessment scales

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 tDCS-Sham<br>tDC stimulation for 3 weeks, then cross-over to sham stimulation | Procedure: transcranial direct current stimulation (tDCS)<br>* Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks<br>|
| Experimental: 2 Sham-tDCS<br>Sham stimulation for 3 weeks, then cross over to tDCS stimulation | Procedure: Sham stimulation, then tDCS<br>* Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks<br>|
| Sham Comparator: 3 Sham-Sham<br>Treatment for 6 weeks daily with sham stimulation | Procedure: Sham stimulation<br>* Sham stimulation for 30 seconds on 15 days during 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment Upper Extremity | Investigator administered questionnaire | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment Upper Extremity | Investigator administered questionnaire | 3 weeks | 
| Fugl-Meyer Assessment Upper Extremity | Investigator administered questionnaire | 6 months | 
| Barthel Index | Investigator administered questionnaire | 3 weeks | 
| Barthel Index | Investigator administered questionnaire | 6 weeks | 
| Barthel Index | Investigator administered questionnaire | 6 months | 
| Ashworth scale | Investigator administered questionnaire | 3 weeks | 
| Ashworth scale | Investigator administered questionnaire | 6 weeks | 
| Ashworth scale | Investigator administered questionnaire | 6 months | 
| Test of Upper Limb Apraxia (TULIA) | investigator administered questionnaire | 6 weeks | 
| Test of Upper Limb Apraxia (TULIA) | investigator administered questionnaire | 6 months | 
| Grip strength | Jamar Hydraulic Hand dynamometer | 3 weeks | 
| Grip strength | Jamar Hydraulic Hand dynamometer | 6 weeks | 
| Grip strength | Jamar Hydraulic Hand dynamometer | 6 months | 
| Hamilton depression Rating scale | Patient administered questionnaire | 6 weeks | 
| Hamilton depression Rating scale | Patient administered questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiparesis, bihemispheric transcranial direct current stimulation, ischemic stroke, subacute, rehabilitation, physiotherapy, ergotherapy