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Bihemispheric Modulation of the Motor Cortex by Transcranial Direct Current Stimulation in Subacute Stroke Patients

Bihemispheric Modulation of the Motor Cortex by Single-session Transcranial Direct Current Stimulation During Training in Subacute Stroke Patients

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02158312
Enrollment
30
Registered
2014-06-06
Start date
2014-05-31
Completion date
2017-12-31
Last updated
2014-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

neuroplasticity

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.

Detailed description

We will consecutively enroll subacute (2-4 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 assessed for baseline upper extremity motor function (Fugl-Meyer test and Action Research Arm test), structural and functional magnetic resonance imaging (fMRI). A single session of bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or sham tDCS (same but stimulation for only 2 min) with simultaneous physical/occupational therapy will be tested in each subject with a randomized sequence on different days (at least two days apart from each other). All stroke patients will receive standard medical and rehabilitation treatments during the study period. Changes in corticospinal excitability and transcallosal inhibition from the TMS study, as well as sensorimotor oscillations, MEG source projection, and functional connectivity from the task-related MEG will be assessed immediately before and after intervention.

Interventions

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

2 mA for 20 minutes transcranial direct current stimulation

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
transcranial magnetic stimulation (TMS)up to 20 minutes

Countries

Taiwan

Contacts

Primary ContactI-Hui Lee, M.D., Ph.D.
ihlee@vghtpe.gov.tw+ 886-2-28712121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026