Clinical trial NCT04340973: Comparing Transcranial Direct Current Stimulation Montages in Stroke
Official title: Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
Keywords: tDCS
Acute Stroke
WMFT
SWMT
Fugl Meyer
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Wolf Motor Function Test
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Change in Fugl Meyer Motor Assessment
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Change in Semmes Weinstein Monofilament Test
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege Univeristy Hospital
Study officials:
References:
citation: 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.