Comparing Transcranial Direct Current Stimulation Montages in Stroke
- Conditions
- Acute Stroke
- Interventions
- Device: Transcranial Direct Current Stimulation
- Registration Number
- NCT04340973
- Lead Sponsor
- University of Liege
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- First Ever Stroke
- Motor or sensory deficit
- Understands and follows orders
- Signed inform consent
- One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Transcranial Direct Current Stimulation 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 Cathodal Transcranial Direct Current Stimulation 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 Transcranial Direct Current Stimulation Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks Bilateral Transcranial Direct Current Stimulation 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 Anodal Transcranial Direct Current Stimulation 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
- Primary Outcome Measures
Name Time Method Change in Wolf Motor Function Test Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 Functional upper limb test, filmed and scored subjectively
Change in Fugl Meyer Motor Assessment Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 Functional upper limb, lower limb and sensory test
Change in Semmes Weinstein Monofilament Test Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 11 Point Sensory test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Liege Univeristy Hospital
🇧🇪Liege, Belgium