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

N/ACompletedNCT02082015

Seoul National University Bundang Hospital77 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stroke Hemiplegia

Interventions

Low frequency rTMSDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 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

Locations (3)

DongGuk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Box and Block Test (affected hand)

Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS

Time frame: up to 17 days

Secondary Outcomes

Box and Block Test (Affected and unaffected hand)

Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

Time frame: up to 40 days

Barthel Index