rTMS and Conventional Physical Therapy After Stroke

Completed

Phase 2 Results N/A

Trial Description

Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.

Conditions

Interventions

  • RTMS Device
    Intervention Desc: The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the motor cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 1Hz on the uninjured hemisphere by stroke; 1500 pulses with an intensity of 90% of MT 10 sessions of rTMS, one per day, always before conventional physical therapy
    ARM 1: Kind: Experimental
    Label: rTMS
    Description: The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy
  • Conventional Physical Therapy Device
    Intervention Desc: The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.
    ARM 1: Kind: Experimental
    Label: rTMS
    Description: The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy
    ARM 2: Kind: Experimental
    Label: control
    Description: The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and conventional physical therapy

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Modified Ashworth scale at baseline, 1 month and 2 months No
Primary change from spinal excitability via Hoffmann reflex of the median nerve at baseline, 1 month and 2 months No
Secondary change from Fugl-Meyer assessment at baseline, 1 month and 2 months No
Secondary change from cortical excitability via single transcranial magnetic stimulation per-session: at baseline and one hour (after physical therapy) No

Sponsors