Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Device: Bihemispheric transcranial direct current stimulation

• Registration Number: NCT02731508
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-30
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
True stimulation	Bihemispheric transcranial direct current stimulation	True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions
Sham stimulation	Bihemispheric transcranial direct current stimulation	Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer test	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke	stroke motor function scale

Secondary Outcome Measures

Name	Time	Method
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
Ipsilateral silent period	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
Resting state functional connectivity	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke	Functional MRI
Short interval intracortical inhibition	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke	Transcranial magnetic stimulation test
Modified Rankin Scale	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke	Global disability poststroke
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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei city, Taiwan