Comparing Transcranial Direct Current Stimulation Montages in Stroke

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340973
• Other study ID #: 2017-94
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: May 2020
• Source: University of Liege
• Contact: Stephen Bornheim, Msc
• Phone: 003243662193
• Email: stephen.bornheim[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Device:
• Transcranial Direct Current Stimulation
Subjects received a micro-current through their scalp to induce cortical and subcortical changes

Locations

Country	Name	City	State
Belgium	Liege Univeristy Hospital	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Semmes Weinstein Monofilament Test	11 Point Sensory test	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4