Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Stroke Clinical Trial

Official title:

Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731508
• Other study ID #: 2015-03-003C
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2022

Study information

• Verified date: November 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: I-Hui Lee, M.D., Ph.D.
• Phone: + 886-2-28712121
• Email: ihlee[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Bihemispheric transcranial direct current stimulation
5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer test	stroke motor function scale	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Action Research Arm test	stroke motor function scale	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Modified Rankin Scale	Global disability poststroke	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Resting state functional connectivity	Functional MRI	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Motor evoked potential	Transcranial magnetic stimulation test	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Active motor threshold	Transcranial magnetic stimulation test	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Ipsilateral silent period	Transcranial magnetic stimulation test	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Short interval intracortical inhibition	Transcranial magnetic stimulation test	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Motor task ERD peak amplitude	magnetoencephalography	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
Secondary	Motor task ERS peak amplitude	magnetoencephalography	baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke