Bihemispheric Modulation of the Motor Cortex by Transcranial Direct Current Stimulation in Subacute Stroke Patients

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT02158312

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Bihemispheric Modulation of the Motor Cortex by Single-session Transcranial Direct Current Stimulation During Training in Subacute Stroke Patients

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: transcranial direct current stimulation bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, for 20 minutes	Device: Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK) 2 mA for 20 minutes transcranial direct current stimulation
Placebo Comparator: sham stimulation same as the experimental stimulation condition but only for 2 minutes

Arm

Intervention/Treatment

Experimental: transcranial direct current stimulation

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

Device: Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)

2 mA for 20 minutes transcranial direct current stimulation

Placebo Comparator: sham stimulation

same as the experimental stimulation condition but only for 2 minutes

Outcome Measures

Primary Outcome Measures

transcranial magnetic stimulation (TMS) [up to 20 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	11217

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

Principal Investigator: I-Hui Lee, MD PhD, Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT02158312

Other Study ID Numbers:

2014-01-006C

First Posted:

Jun 6, 2014

Last Update Posted:

Jun 6, 2014

Last Verified:

Jun 1, 2014

Keywords provided by Taipei Veterans General Hospital, Taiwan

neuroplasticity

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 6, 2014