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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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