Intermittent Theta Burst Stimulation After Acute Stroke

Phase 1

Completed

• Conditions: Ischemic Stroke,
• Interventions: Device: Intermittent theta burst stimulation

• Registration Number: NCT01323881
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2009-05
• Study Start: 2009-05
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-28
• Primary Completion: 2012-12
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent theta burst stimulation	Intermittent theta burst stimulation	-

Primary Outcome Measures

Name	Time	Method
The changes of Action Research Arm test	60th day post-stroke	We assess the changes of Action Research Arm test between before the intervention and the 60th day post-stroke.

Secondary Outcome Measures

Name	Time	Method
The changes of upper limb function and corticospinal excitability	60th day post-stroke	We assess the changes of Fugl-Meyer test (FMT), active motor threshold and motor evoked potentials (MEPs) of paretic ECR between before the intervention and 60th day post-stroke

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei city, Taiwan