Transcranial Direct Current Stimulation Acute Stroke Walking

Acute Stroke Clinical Trial

Official title:

Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349488
• Other study ID #: 2016/287
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: April 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

16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.

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.

The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up & Go and the 10 meter walking test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 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:
• Anodal 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	Changes Four Square Step Test	The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Primary	Changes Berg Balance Scale	Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Primary	Changes Postural Assessment Scale For Stroke	alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Primary	Changes Trunk Impairment Scale	alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Primary	Changes Time Up & Go	To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Primary	Changes 10 meter walking test	10 meter walking test, the faster the better	Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4