The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement

MinYoung Kim, MD, PhD

Status: Enrolling

Conditions: Stroke

Treatments: Device: rTMS; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06322797

rTMSinStroke

Details and patient eligibility

About

A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.

Full description

Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes.

However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment.

Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields.

Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities.

The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.

Enrollment: 15 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adults over 20 years of age
• Patients 3 months or more after stroke onset
• Patients with NIHSS score of 1 or more to 20 or less
• After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions

Exclusion Criteria: Patients who fall under one or more of the following conditions are not eligible to participate in the study.

• Patients with systemic infectious disease at the time of participation in the clinical trial
• In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
• Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
• Other cases where the researcher determines that participation in this clinical trial is not appropriate
• Those who are contraindicated in repetitive transcranial magnetic stimulation A. When metal materials (deep brain stimulation electrode, brain aneurysm clip, cardiac pacemaker, etc.) are in the body B. Uncontrolled epilepsy (epilepsy), patients with psychiatric disorders
• Pregnant, lactating women and patients with potential for pregnancy
• Patients with contraindications for imaging tests
• Those who have undergone cerebral surgery due to past or current related medical history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups

rTMS over the M1 cortex of the injured hemisphere localized by motor action potential

Experimental group

Description:

Experimental A group : rTMS was administered by trained physicians over the M1 cortex of the injured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb.

Treatment:

Device: rTMS

Device: rTMS

rTMS over the specific site of the injured hemisphere localized by fMRI

Experimental group

Description:

Experimental B group : rTMS was administered by trained physicians over the specific site which is after checking the brain site activated during finger tapping during fMRI imaging, target coordinates are set based on the 10-20 EEG system coordinate system in the taken MRI image.

Treatment:

Device: rTMS

Device: rTMS

Sham group

Sham Comparator group

Description:

Sham group: shame rTMS( sound mode) is applied over the M1 cortex of the injured hemisphere which is the site that caused the largest visible twitch in the participant's thumb when stimulation is applied

Treatment:

Device: Sham