Intermittent Theta Burst Stimulation After Acute Stroke

Ischemic Stroke, Clinical Trial

Official title: Theta Burst Stimulation on the Motor Cortex in Acute Stroke: a Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke,
• Stroke

• NCT number: NCT01323881
• Study type: Interventional
• Source: Taipei Veterans General Hospital, Taiwan
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2009