Stroke
Conditions
Keywords
Transcranial Direct Current Stimulation, Neuroplasticity
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.
Interventions
DEVICEBihemispheric transcranial direct current stimulation
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer test | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | stroke motor function scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | Global disability poststroke |
| Resting state functional connectivity | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | Functional MRI |
| Motor evoked potential | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | Transcranial magnetic stimulation test |
| Active motor threshold | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | Transcranial magnetic stimulation test |
| Action Research Arm test | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | stroke motor function scale |
| Short interval intracortical inhibition | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | Transcranial magnetic stimulation test |
| Motor task ERD peak amplitude | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | magnetoencephalography |
| Motor task ERS peak amplitude | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | magnetoencephalography |
| Ipsilateral silent period | baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke | Transcranial magnetic stimulation test |
Countries
Taiwan
Contacts
Primary ContactI-Hui Lee, M.D., Ph.D.
Outcome results
None listed