Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients "TAMAS"

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.
Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.
The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.

Conditions

Interventions

  • Low frequency rTMS Device
    Other Names: TMS
    Intervention Desc: Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
    ARM 1: Kind: Experimental
    Label: true coil
    Description: Use the true coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
    ARM 2: Kind: Experimental
    Label: sham coil
    Description: Use the sham coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Box and Block Test (affected hand) up to 17 days No
Secondary Box and Block Test (Affected and unaffected hand) up to 40 days No
Secondary Barthel Index up to 40 days No
Secondary National Institutes of Health Stroke Scale up to 40 days No
Secondary Fugl-Meyer Assessment Scale up to 40 days No
Secondary Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck) up to 40 days
Secondary Finger tapping up to 40 days
Secondary B-stage (hand and arm) up to 40 days
Secondary Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity) up to 40 days

Sponsors