- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340973
Comparing Transcranial Direct Current Stimulation Montages in Stroke
Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Liege, Belgium, 4000
- Recruiting
- Liege Univeristy Hospital
-
Contact:
- Stephen Bornheim, Msc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Anodal
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
|
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
|
Active Comparator: Bilateral
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
|
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
|
Active Comparator: Cathodal
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
|
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
|
Active Comparator: Extracephalic
Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks
|
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
|
Placebo Comparator: Placebo
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
|
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Wolf Motor Function Test
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
|
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
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
|
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
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
|
11 Point Sensory test
|
Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-94
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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