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

NCT06322797 | Recruiting

• 1 other identifier: rTMSinStroke
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Functional Magnetic Resonance Imaging; Repetitive transcranial magnetic stimulation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change of Fugl-Meyer Assessment

  The difference in the FMA (Fugl-Meyer Assessment) between the three groups at baseline, 30 days and 90 days was confirmed by comparing differences.\[0\~66 for each arm\] (The higher values represent a better outcome.)

  Baseline - 1month - 3months

Secondary Outcomes (23)

• Change of Range of motion

  Baseline - 1month - 3months

• Change of Berg Balance Scale

  Baseline - 1month - 3months

• Change of Motor Assessment Scale

  Baseline - 1month - 3months

• Change of Trunk Imbalance Scale

  Baseline - 1month - 3months

• Change of Functional Ambulation Category

  Baseline - 1month - 3months

Study Arms (3)

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

EXPERIMENTAL

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.

Device: rTMS

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

EXPERIMENTAL

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.

Device: rTMS

Sham group

SHAM COMPARATOR

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

Device: Sham

Interventions

rTMS DEVICE

Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. First, the resting motor threshold was measured for each patient. At the lowest stimulus output, a stimulus was applied to the M1 cortex of the uninjured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. The resting motor threshold was defined as the intensity required to generate a motor-induced potential of \> 50 uV in the contralateral abductor pollicis brevis muscle at least 5 out of 10 times with 30 s of inter-stimulus time interval. Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min.

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

Sham DEVICE

In Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups.

Sham group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MinYoung Kim, MD, PhD: lead

Study Sites (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, 13496, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kim MinYoung, M.D., Ph.D.

  CHA University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim MinYoung, M.D., Ph.D.

CONTACT

82-31-780-6281; kmin@cha.ac.kr

Kim JongMoon, M.D.

CONTACT

82-31-780-6281; khan1013@chamc.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of CHA university, M.D., Ph.D.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: March 21, 2024
• Study Start: July 19, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)