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Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

NCT ID: NCT02731508

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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Transcranial Direct Current Stimulation Neuroplasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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True stimulation

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

Group Type EXPERIMENTAL

Bihemispheric transcranial direct current stimulation

Intervention Type DEVICE

5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation

Sham stimulation

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

Group Type SHAM_COMPARATOR

Bihemispheric transcranial direct current stimulation

Intervention Type DEVICE

5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation

Interventions

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Bihemispheric transcranial direct current stimulation

5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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I-Hui Lee, M.D., Ph.D.

Role: CONTACT

Phone: + 886-2-28712121

Email: [email protected]

Facility Contacts

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i-hui Lee, MD, PhD

Role: primary

References

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Hsu SP, Lu CF, Lin BF, Tang CW, Kuo IJ, Tsai YA, Guo CY, Lee PL, Shyu KK, Niddam DM, Lee IH. Effects of bihemispheric transcranial direct current stimulation on motor recovery in subacute stroke patients: a double-blind, randomized sham-controlled trial. J Neuroeng Rehabil. 2023 Feb 27;20(1):27. doi: 10.1186/s12984-023-01153-4.

Reference Type DERIVED
PMID: 36849990 (View on PubMed)

Other Identifiers

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2015-03-003C

Identifier Type: -

Identifier Source: org_study_id