Comparing Transcranial Direct Current Stimulation Montages in Stroke

Study Overview
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Brief Summary
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40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo. Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week. Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test

Detailed Description
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40 acute subjects will be randomized and split into 5 groups. Each group will receive one of the following tDCS montages : Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down. Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 2mA for 20 mins of their attributed tDCS, 5 times a week. Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine

Official Title
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Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First Ever Stroke Motor or sensory deficit Understands and follows orders Signed inform consent Exclusion Criteria: One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Interventional Model Description: 5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anodal<br>Anodal tDCS: Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|
| Active Comparator: Bilateral<br>Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|
| Active Comparator: Cathodal<br>Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|
| Active Comparator: Extracephalic<br>Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|
| Placebo Comparator: Placebo<br>Placebo : anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wolf Motor Function Test | Functional upper limb test, filmed and scored subjectively | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Change in Fugl Meyer Motor Assessment | Functional upper limb, lower limb and sensory test | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Change in Semmes Weinstein Monofilament Test | 11 Point Sensory test | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, Acute Stroke, WMFT, SWMT, Fugl Meyer