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Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bihemispheric transcranial direct current stimulation
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Transcranial Direct Current Stimulation, Neuroplasticity

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

True stimulation

Sham stimulation

Arm Description

True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions

Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds

Outcomes

Primary Outcome Measures

Fugl-Meyer test
stroke motor function scale

Secondary Outcome Measures

Action Research Arm test
stroke motor function scale
Modified Rankin Scale
Global disability poststroke
Resting state functional connectivity
Functional MRI
Motor evoked potential
Transcranial magnetic stimulation test
Active motor threshold
Transcranial magnetic stimulation test
Ipsilateral silent period
Transcranial magnetic stimulation test
Short interval intracortical inhibition
Transcranial magnetic stimulation test
Motor task ERD peak amplitude
magnetoencephalography
Motor task ERS peak amplitude
magnetoencephalography

Full Information

First Posted
February 15, 2016
Last Updated
November 23, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02731508
Brief Title
Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke
Official Title
Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Transcranial Direct Current Stimulation, Neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
True stimulation
Arm Type
Experimental
Arm Description
True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds
Intervention Type
Device
Intervention Name(s)
Bihemispheric transcranial direct current stimulation
Intervention Description
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
Primary Outcome Measure Information:
Title
Fugl-Meyer test
Description
stroke motor function scale
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary Outcome Measure Information:
Title
Action Research Arm test
Description
stroke motor function scale
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Modified Rankin Scale
Description
Global disability poststroke
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Resting state functional connectivity
Description
Functional MRI
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Motor evoked potential
Description
Transcranial magnetic stimulation test
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Active motor threshold
Description
Transcranial magnetic stimulation test
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Ipsilateral silent period
Description
Transcranial magnetic stimulation test
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Short interval intracortical inhibition
Description
Transcranial magnetic stimulation test
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Motor task ERD peak amplitude
Description
magnetoencephalography
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Title
Motor task ERS peak amplitude
Description
magnetoencephalography
Time Frame
baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Hui Lee, M.D., Ph.D.
Phone
+ 886-2-28712121
Ext
8109
Email
ihlee@vghtpe.gov.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei city
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
i-hui Lee, MD, PhD
Phone
886-2-28712121
Ext
8109
Email
ihui_lee@hotmail.com
First Name & Middle Initial & Last Name & Degree
i-hui Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

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