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

NCT ID: NCT02158312

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

transcranial direct current stimulation

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

2 mA for 20 minutes transcranial direct current stimulation

sham stimulation

same as the experimental stimulation condition but only for 2 minutes

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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

2 mA for 20 minutes transcranial direct current stimulation

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I-Hui Lee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

I-Hui Lee, M.D., Ph.D.

Role: CONTACT

ihlee@vghtpe.gov.tw

+ 886-2-28712121 ext. 8109

Facility Contacts

I-Hui Lee, M.D., Ph.D.

Role: primary

ihlee@vghtpe.gov.tw

+ 886-2-28712121 ext. 8109

Other Identifiers

2014-01-006C

Identifier Type: -

Identifier Source: org_study_id