Clinical trial NCT02731508: Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke
Official title: Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Transcranial Direct Current Stimulation
Neuroplasticity
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-04-07
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer test
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary outcomes:
measure: Action Research Arm test
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Modified Rankin Scale
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Resting state functional connectivity
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Motor evoked potential
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Active motor threshold
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Ipsilateral silent period
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Short interval intracortical inhibition
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Motor task ERD peak amplitude
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
measure: Motor task ERS peak amplitude
timeFrame: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: