Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

November 23, 2021 updated by: Taipei Veterans General Hospital, Taiwan

Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke

Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. In this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be randomly allocated to receive daily bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or daily sham tDCS (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. Changes in upper extremity motor function score (Fugl-Meyer test and Action Research Arm test), corticospinal excitability from the transcranial magnetic stimulation(TMS), and sensorimotor oscillations from the magnetoencephalography (MEG) will be assessed before and after intervention, as well as 3 months after stroke. All stroke patients will receive tDCS and standard medical, rehabilitation treatments in rehabilitation ward.

Study Type

Interventional

Enrollment (Anticipated)

32

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 Contact

Study Locations

  • Taiwan
      • Taipei city, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • i-hui Lee, MD, PhD

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-80 years old
  • Patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness
  • Brain MRI confirmed subcortical stroke in the middle cerebral artery territory
  • Post-stroke 2-6 weeks with stable clinical condition

Exclusion Criteria:

  • Stroke with cortical lesions
  • Containing metal implants (such as implanted electrodes, pacemakers)
  • Sensitive or fear of electromagnetic waves
  • Pregnant women
  • History of alcohol or drug abuse
  • History of seizures or epilepsy
  • Claustrophobia
  • Other significant disease or neuropsychiatric disorders

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: True stimulation
True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions
Device: Bihemispheric transcranial direct current stimulation
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
Sham Comparator: Sham stimulation
Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds
Device: Bihemispheric transcranial direct current stimulation
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer test
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
stroke motor function scale
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm test
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
stroke motor function scale
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Modified Rankin Scale
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Global disability poststroke
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Resting state functional connectivity
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Functional MRI
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor evoked potential
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Transcranial magnetic stimulation test
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Active motor threshold
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Transcranial magnetic stimulation test
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Ipsilateral silent period
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Transcranial magnetic stimulation test
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Short interval intracortical inhibition
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Transcranial magnetic stimulation test
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERD peak amplitude
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
magnetoencephalography
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Motor task ERS peak amplitude
Time Frame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
magnetoencephalography
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

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

October 1, 2015

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-03-003C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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