Transcranial Direct Current Stimulation Acute Stroke Walking

April 23, 2020 updated by: Bornheim Stephen, University of Liege

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • Liege Univeristy Hospital
        • Contact:
          • Stephen Bornheim, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Treatment
Anode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks
Device: Anodal Transcranial Direct Current Stimulation
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
  • tDCS
Placebo Comparator: 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
Device: Anodal Transcranial Direct Current Stimulation
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes Four Square Step Test
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
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
Changes Berg Balance Scale
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
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
Changes Postural Assessment Scale For Stroke
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
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
Changes Trunk Impairment Scale
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
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
Changes Time Up & Go
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
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
Changes 10 meter walking test
Time Frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
10 meter walking test, the faster the better
Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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