Intermittent Theta Burst Stimulation After Acute Stroke

Taipei Veterans General Hospital

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ischemic Stroke,

Treatments

Device: Intermittent theta burst stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01323881

VGHIRB98-05-05

Details and patient eligibility

About

This pilot sham-controlled study aims to determine the safety and efficacy of repetitive transcranial magnetic stimulation given as a facilitatory intermittent theta burst stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute stroke patients.

Full description

The patients with first-ever, MRI-confirmed monohemispheric ischemic stroke in the middle cerebral artery territory, and NIH Stroke Scale motor arm score 1-2 with recordable active motor thresholds (aMT) of the extensor carpi radialis (ECR) between 2-4 weeks after the stroke onset, are randomized into two groups to receive either iTBS1200 or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. All have standardized medical and intensive rehabilitation treatments. The outcome measures included Action Research Arm test (ARAT), Fugl-Meyer test (FMT), aMT and motor evoked potentials (MEPs) of ECR.

Enrollment

20 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients with first-ever, subacute (between 2-4 weeks post-stroke), monohemispheric ischemic stroke within the middle cerebral artery (MCA) territory, and mild to moderate hand paresis (NIHSS motor arm score 1-2) are enrolled.

Exclusion criteria

age over 75, severe hand paresis without detectable active motor threshold (aMT) of the extensor carpi radialis (ECR), seizure history (clinical or EEG abnormalities), psychosis, aphasia, apraxia, concomitant neurological diseases or severe systemic diseases (e.g. sepsis, advanced malignancy, hepatic or renal failure.