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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal | Active Comparator | 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 |
|
| Bilateral | Active Comparator | 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 |
|
| Cathodal | Active Comparator | 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 |
|
| Extracephalic | Active Comparator | Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
|
| Placebo | Placebo Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | Subjects received a micro-current through their scalp to induce cortical and subcortical changes |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Bornheim, Msc | Contact | 003243662193 | stephen.bornheim@uliege.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liege Univeristy Hospital | Recruiting | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30431445 | Background | Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study
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Everyone is blinded, codes are selected by a third party not involved in any step of the study
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |