NCT02158312

Brief Summary

Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance after-effects of rehabilitation through membrane polarization modulation. In this double-blind, crossover randomized controlled trial, we aim to investigate whether single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy modulates 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
30

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started May 2014

Typical duration for phase_1 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

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

3 years

First QC Date

June 4, 2014

Last Update Submit

June 5, 2014

Conditions

Stroke

Keywords

neuroplasticity

Outcome Measures

Primary Outcomes (1)

  • transcranial magnetic stimulation (TMS)

    up to 20 minutes

Study Arms (2)

transcranial direct current stimulation

EXPERIMENTAL

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

Device: Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)

sham stimulation

PLACEBO COMPARATOR

same as the experimental stimulation condition but only for 2 minutes

Interventions

Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)DEVICE

2 mA for 20 minutes transcranial direct current stimulation

transcranial direct current stimulation

Eligibility Criteria

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

You may qualify if:

  • subacute (2-4 weeks after stroke onset) patients
  • first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory
  • mild to moderate hand weakness (MRC 2-4/5)

You may not qualify if:

  • cerebral cortex 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 EEG recording
  • other significant disease or neuropsychiatric disorders
  • claustrophobia
  • fixed dentures over two or more (enough to interfere with MEG signals)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • I-Hui Lee, MD PhD

    Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

TW(1)