Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

Terminated

Phase 2/3 Results N/A

Trial Description

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.

Trial Stopped: Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) Device
    Intervention Desc: 1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, Real: unaffected M1 hotspot Sham: coil perpendicular to scalp
    ARM 1: Kind: Experimental
    Label: Sham rTMS-Sham rTMS
    Description: Sham rTMS for 2 weeks
    ARM 2: Kind: Experimental
    Label: Sham rTMS-Real rTMS
    Description: Sham rTMS in the first week and real rTMS in the second week
    ARM 3: Kind: Experimental
    Label: Real rTMS-Real rTMS
    Description: Real rTMS for 2 weeks

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in the Fugl-Meyer Assessment scale (upper extremity) Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up No
Secondary Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up No

Sponsors