Clinical trial NCT06322797: The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement
Official title: A Randomized, Controlled, Patient- and Assessor- Blinded, Exploratory Clinical Trial to Search the Stimulation Site for Repetitive Transcranial Magnetic Stimulation (rTMS) That Improves Upper Extremity Function After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Functional Magnetic Resonance Imaging
Repetitive transcranial magnetic stimulation
Rehabilitation
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change of Fugl-Meyer Assessment
timeFrame: Baseline - 1month - 3months
Secondary outcomes:
measure: Change of Range of motion
timeFrame: Baseline - 1month - 3months
measure: Change of Berg Balance Scale
timeFrame: Baseline - 1month - 3months
measure: Change of Motor Assessment Scale
timeFrame: Baseline - 1month - 3months
measure: Change of Trunk Imbalance Scale
timeFrame: Baseline - 1month - 3months
measure: Change of Functional Ambulation Category
timeFrame: Baseline - 1month - 3months
measure: Change of Time up and go
timeFrame: Baseline - 1month - 3months
measure: Change of Manual muscle Test
timeFrame: Baseline - 1month - 3months
measure: Change of Action reach arm test
timeFrame: Baseline - 1month - 3months
measure: Change of Jebsen taylor hand function test
timeFrame: Baseline - 1month - 3months
measure: Change of Functional Independence Measure
timeFrame: Baseline - 1month - 3months
measure: Change of Modified Barthel index
timeFrame: Baseline - 1month - 3months
measure: Change of National Institutes of Health Stroke Scale
timeFrame: Baseline - 1month - 3months
measure: Change of Korean Mini Mental State Exam
timeFrame: Baseline - 1month - 3months
measure: Change of Clinical Dementia Rating
timeFrame: Baseline - 1month - 3months
measure: Change of Global Deterioration Scale
timeFrame: Baseline - 1month - 3months
measure: Change of Geriatric Depression Scale
timeFrame: Baseline - 1month - 3months
measure: Change of Brain imaging
timeFrame: Baseline - 1month - 3months
measure: Change of Electroencephalography
timeFrame: Baseline - 1month - 3months
measure: Change of Evoked Potential
timeFrame: Baseline - 1month - 3months
measure: Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL)
timeFrame: Baseline - 1month - 3months
measure: Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL)
timeFrame: Baseline - 1month - 3months
measure: Changes in test results of AST(IU/L), ALT(IU/L)
timeFrame: Baseline - 1month - 3months
measure: Change of Motricity index
timeFrame: Baseline - 1month - 3months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
Study officials:
affiliation: CHA University
name: Kim MinYoung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: