NCT01323881

Intermittent Theta Burst Stimulation After Acute Stroke

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemic Stroke,

Interventions

Type	Name	Description
DEVICE	Intermittent theta burst stimulation	Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-12-01
• First posted: 2011-03-28
• Last updated: 2014-05-26

Locations

1 site across 1 country: Taiwan