Bihemispheric Modulation of the Motor Cortex by Transcranial Direct Current Stimulation in Subacute Stroke Patients
Primary Purpose
Stroke
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring neuroplasticity
Eligibility Criteria
Inclusion Criteria:
- subacute (2-4 weeks after stroke onset) patients
- first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory
- mild to moderate hand weakness (MRC 2-4/5)
Exclusion Criteria:
- cerebral cortex 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 EEG recording
- other significant disease or neuropsychiatric disorders
- claustrophobia
- fixed dentures over two or more (enough to interfere with MEG signals)
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
transcranial direct current stimulation
sham stimulation
Arm Description
bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, for 20 minutes
same as the experimental stimulation condition but only for 2 minutes
Outcomes
Primary Outcome Measures
transcranial magnetic stimulation (TMS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02158312
First Posted
June 4, 2014
Last Updated
June 5, 2014
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02158312
Brief Title
Bihemispheric Modulation of the Motor Cortex by Transcranial Direct Current Stimulation in Subacute Stroke Patients
Official Title
Bihemispheric Modulation of the Motor Cortex by Single-session Transcranial Direct Current Stimulation During Training in Subacute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (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
Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance after-effects of rehabilitation through membrane polarization modulation. In this double-blind, crossover randomized controlled trial, we aim to investigate whether single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy modulates ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.
Detailed Description
We will consecutively enroll subacute (2-4 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 assessed for baseline upper extremity motor function (Fugl-Meyer test and Action Research Arm test), structural and functional magnetic resonance imaging (fMRI). A single session of bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or sham tDCS (same but stimulation for only 2 min) with simultaneous physical/occupational therapy will be tested in each subject with a randomized sequence on different days (at least two days apart from each other). All stroke patients will receive standard medical and rehabilitation treatments during the study period. Changes in corticospinal excitability and transcallosal inhibition from the TMS study, as well as sensorimotor oscillations, MEG source projection, and functional connectivity from the task-related MEG will be assessed immediately before and after intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
neuroplasticity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcranial direct current stimulation
Arm Type
Experimental
Arm Description
bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, for 20 minutes
Arm Title
sham stimulation
Arm Type
Placebo Comparator
Arm Description
same as the experimental stimulation condition but only for 2 minutes
Intervention Type
Device
Intervention Name(s)
Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)
Intervention Description
2 mA for 20 minutes transcranial direct current stimulation
Primary Outcome Measure Information:
Title
transcranial magnetic stimulation (TMS)
Time Frame
up to 20 minutes
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:
subacute (2-4 weeks after stroke onset) patients
first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory
mild to moderate hand weakness (MRC 2-4/5)
Exclusion Criteria:
cerebral cortex 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 EEG recording
other significant disease or neuropsychiatric disorders
claustrophobia
fixed dentures over two or more (enough to interfere with MEG signals)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Hui Lee, MD PhD
Organizational Affiliation
Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I-Hui Lee, M.D., Ph.D.
Phone
+ 886-2-28712121
Ext
8109
Email
ihlee@vghtpe.gov.tw
12. IPD Sharing Statement
Learn more about this trial
Bihemispheric Modulation of the Motor Cortex by Transcranial Direct Current Stimulation in Subacute Stroke Patients
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