Intermittent Theta Burst Stimulation After Acute Stroke

Completed

Phase 1/2 Results N/A

Trial Description

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

Interventions

  • Intermittent theta burst stimulation Device
    Intervention Desc: Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks.
    ARM 1: Kind: Experimental
    Label: intermittent theta burst stimulation

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary The changes of Action Research Arm test 60th day post-stroke Yes
Secondary The changes of upper limb function and corticospinal excitability 60th day post-stroke Yes

Sponsors