The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

January 8, 2026 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

Multi-center, Prospective, Comparative, Randomized, Double Blind, Superior, Pivotal Study to Compare and Evaluate the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Applied With an Electromagnetic Therapy Stimulator 'ALTMS-A' for Upper-limb Motor Function Recovery With the Sham Control Group for Those Who Need Upper-limb Rehabilitation Treatment for Subcortical and Brainstem Stroke (Ischemic)

The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement.

Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations.

The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Daejeon, South Korea, 35015
        • Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
    • Korea, Gyeonggi-do
      • Seongnam-si, Korea, Gyeonggi-do, South Korea, 463-707
        • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 19-80 years old
  • Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days
  • Fugl-Meyer assessment scale (upper extremity) > 15
  • Mini-mental status exam (the Korean version) > 14 with appropriate cognitive function
  • Written informed consent

Exclusion Criteria:

  • Fugl-Meyer assessment scale (wrist) < 1 or Fugl-Meyer assessment scale (hand) < 1
  • Hemorrhagic stroke or traumatic brain injury
  • Cerebellar stroke
  • Previous history of stroke
  • Traumatic brain injury
  • Previous history of brain surgery
  • Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability)
  • History of psychological or neurological diseases
  • History of pain or muscular weakness of upper limbs which may interfere with rehabilitation
  • History of seizure or epilepsy
  • Aphasia
  • Skin lesions in the stimulation site of scalp
  • Intracranial metal implant
  • Inability to receive regular physical or occupational therapy
  • Disagreement to use contraception in women of childbearing age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: real rTMS
Use the real rTMS coil
Device: Low-frequency rTMS (experimental)
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp
Sham Comparator: sham rTMS
Use the sham rTMS coil
Device: Low-frequency rTMS (sham comparator)
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block test
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block test
Time Frame: upto 14 days
Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS
upto 14 days
Fugl-Meyer Assessment Scale
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
modified Barthel Index (the Korean version)
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
National Institutes of Health Stroke Scale
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
Finger tapping
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
Brunnstrom stage (hand and arm)
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Time Frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital sign
Time Frame: upto 42 days
Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Chungnam National University Hospital

Investigators

  • Principal Investigator: Nam-Jong Paik, MD, PhD, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-2205-756-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Low-frequency rTMS (experimental)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe