Transcranial Stimulation in Motor Stroke Rehabilitation

Study Overview
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Brief Summary
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Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS. Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.

Official Title
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Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS
* Device: rTMS
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic or hemorrhagic stroke (> 6 months from the accident) Exclusion Criteria: general cognitive impairment (Mini Mental State Examination < 25), severe functional disability (Barthel Index < 45), psychiatric disorders, degenerative neurological disorders, epilepsy, severe medical conditions, having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS+rTMS<br>Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation. | Device: tDCS<br>* Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.<br>* Other names: HDC Stim device Newronica;Device: rTMS<br>* Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.<br>* Other names: PowerMAG 100 MAG&More;|
| Experimental: rTMS+tDCS<br>Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation. | Device: tDCS<br>* Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.<br>* Other names: HDC Stim device Newronica;Device: rTMS<br>* Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.<br>* Other names: PowerMAG 100 MAG&More;|
| Sham Comparator: Sham stimulation<br>Stroke patients were treated with two weeks of sham transcranial direct current stimulation. | Device: Sham<br>* Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.<br>* Other names: HDC Stim device Newronica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement) | Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment. | Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P300 (latency) | The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. Investigators measured the latency of the component 1 week before first treatment; 1 week after first treatment; 1 week before second treatment; 1 week after second treatment. | Baseline; 1 month; 6 months and 1 week; 7 months | 
| Cognition (standardized neuropsychological assessment) | The patients were evaluated by means of a standardized neuropsychological assessment consisting of a battery of cognitive tests involving the following domains: verbal short-term memory, visuospatial learning, working memory, verbal learning, attention and frontal executive functions, and general cognitive impairment. The assessment was repeated 1 week before first treatment; 1 week after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 6 months follow-up after second treatment. | Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Non Invasive Brain Stimulation