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

Not Applicable

Completed

• Conditions: Hemiplegia; Stroke
• Interventions: Device: Low frequency rTMS

• Registration Number: NCT02082015
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Study Start: 2014-04
• Primary Completion: 2018-01-23
• Study Completion: 2018-02-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• 20-80 yrs old
• Radiologically confirmed ischemic stroke within 90 days
• Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
• Patients received stroke treatment and on secondary prevention medication
• Written informed consent

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Exclusion Criteria

• Previous medical histories of stroke, cerebral vascular operation, seizure
• Pregnancy, Breastfeeding
• Patients with hemorrhagic stroke, traumatic brain injury
• Skin lesion in the stimulation site of scalp
• Metal implants in the body (cardiac pacemaker or aneurysm clip)
• Unable to have regular physical and occupational therapies on the affected hand

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham coil	Low frequency rTMS	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: vertical to scalp
true coil	Low frequency rTMS	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

Primary Outcome Measures

Name	Time	Method
Box and Block Test (affected hand)	up to 17 days	Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS

Secondary Outcome Measures

Name	Time	Method
Finger tapping	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Barthel Index	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Box and Block Test (Affected and unaffected hand)	up to 40 days	Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
National Institutes of Health Stroke Scale	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
B-stage (hand and arm)	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Fugl-Meyer Assessment Scale	up to 40 days	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

Trial Locations

Locations (3)

DongGuk University Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of