NCT02731508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

7 years

First QC Date

February 15, 2016

Last Update Submit

November 23, 2021

Conditions

Stroke

Keywords

Transcranial Direct Current StimulationNeuroplasticity

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer test

    stroke motor function scale

    baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

Secondary Outcomes (9)

  • Action Research Arm test

    baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

  • Modified Rankin Scale

    baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

  • Resting state functional connectivity

    baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

  • Motor evoked potential

    baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

  • Active motor threshold

    baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke

  • +4 more secondary outcomes

Study Arms (2)

True stimulation

EXPERIMENTAL

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

Device: Bihemispheric transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

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

Device: Bihemispheric transcranial direct current stimulation

Interventions

Bihemispheric transcranial direct current stimulationDEVICE

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

Sham stimulationTrue stimulation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36849990DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

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

CONTACT

+ 886-2-28712121ihlee@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

April 7, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)