Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Taipei Veterans General Hospital

Status: Unknown

Conditions: Stroke

Treatments: Device: Bihemispheric transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02731508

2015-03-003C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

True stimulation

Experimental group

Description:

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

Treatment:

Device: Bihemispheric transcranial direct current stimulation

Sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Bihemispheric transcranial direct current stimulation