Comparing Transcranial Direct Current Stimulation Montages in Stroke

May 17, 2020 updated by: Bornheim Stephen, University of Liege

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

Unknown

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

Interventional

Enrollment (Anticipated)

40

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

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)

May 7, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

April 4, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

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

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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