Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation Improves Motor and Functional Outcomes After Ischemic Stroke (rTMS-MOTOR)

February 6, 2026 updated by: Hanoi Medical University

Effects of Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation on Motor and Functional Outcomes in Patients With Ischemic Stroke: A Randomized Sham-Controlled Trial

Ischemic stroke is a leading cause of long-term motor disability, frequently resulting in hemiplegia and limitations in daily activities and quality of life. Motor rehabilitation is a fundamental component of post-stroke care across all stages of recovery; however, functional outcomes may vary, particularly in patients with persistent motor impairment.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been used as an adjunct to rehabilitation to modulate cortical excitability and potentially support motor recovery.

The purpose of this study is to evaluate the effects of low-frequency rTMS combined with conventional motor rehabilitation compared with sham rTMS combined with conventional motor rehabilitation in patients with first-ever ischemic stroke during the acute, subacute, and chronic stages. Motor function, balance, functional mobility, activities of daily living, and stroke-specific quality of life will be assessed at baseline, after the intervention, and at 3-month and 6-month follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, sham-controlled clinical trial designed to evaluate the outcomes of repetitive transcranial magnetic stimulation (rTMS) combined with motor rehabilitation in patients with first-ever ischemic stroke presenting with hemiplegia.Participants will be recruited during the acute (< 1 month), subacute (1-6 months), and chronic (> 6 months) stages after stroke onset.

Eligible participants will be allocated into two groups: a control group and an intervention group. Both groups will receive standardized conventional motor rehabilitation targeting upper and lower limb motor function, balance, and functional mobility.

In the intervention group, participants will receive low-frequency rTMS in addition to conventional motor rehabilitation. rTMS will be delivered at a frequency of 1 Hz, once daily, five days per week, for a total of 20 sessions. For upper limb rehabilitation, stimulation will be applied to the primary motor cortex (M1) corresponding to the hand area of the contralesional hemisphere using a figure-of-eight coil. For lower limb rehabilitation, stimulation will target the leg area of M1 located in the medial interhemispheric region using a Hesed coil. Stimulation intensity will be set relative to each participant's motor threshold, and rTMS sessions will be administered immediately prior to motor rehabilitation.

In the control group, participants will receive sham rTMS combined with the same conventional motor rehabilitation program. Sham stimulation will be performed using identical procedures, participant positioning, coil placement, stimulation duration, and acoustic output as the active rTMS condition. To minimize cortical stimulation, the coil will be positioned perpendicular to the scalp, producing minimal magnetic field penetration while maintaining the characteristic clicking sound of the device.

To ensure blinding, participants will not be informed of their group allocation, and they will be instructed not to disclose any information related to the intervention they received prior to outcome assessments. Outcome assessors will be blinded to group assignment.

Outcome measures will be assessed at baseline, immediately after completion of the intervention, and at 3-month and 6-month follow-up to evaluate motor recovery, balance, functional mobility, activities of daily living, and stroke-specific quality of life.

Study Type

Interventional

Enrollment (Estimated)

66

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 to 80 years.
  • Diagnosed with a first-ever ischemic stroke, confirmed by neuroimaging.
  • Presence of unilateral hemiparesis attributable to the first-ever ischemic stroke.

  • Time since stroke onset:

    • Acute stage: < 1 month after stroke onset
    • Subacute stage: 1 to 6 months after stroke onset
    • Chronic stage: > 6 months after stroke onset
  • Moderate neurological impairment, defined as a baseline NIHSS score between 5 and 14.
  • Cognitive ability sufficient to understand and follow instructions, indicated by a baseline MMSE score ≥ 20.
  • Medically stable and able to participate in a structured motor rehabilitation program.
  • Provided written informed consent prior to study enrollment.
  • NIHSS and MMSE scores are assessed at baseline only to characterize neurological severity and cognitive status at study entry

Exclusion Criteria:

  • Motor impairment caused by conditions other than ischemic stroke, such as musculoskeletal disorders, traumatic brain injury, Parkinson's disease, encephalitis, or other neurological conditions.
  • Contraindications to repetitive transcranial magnetic stimulation, including but not limited to intracranial metallic implants, implanted electronic medical devices (e.g., pacemaker), cochlear implants, known bleeding disorders, pregnancy, history of epilepsy or seizure disorders, severe cardiac disease, severe psychiatric or neurological disorders interfering with participation, or active skin conditions at the stimulation site.
  • History of epilepsy or seizure disorders.
  • Recurrent stroke occurring during the intervention period.
  • Refusal to participate, withdrawal of informed consent, or non-adherence to the intervention protocol.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Participants receive sham rTMS combined with the same standardized conventional motor rehabilitation program. Sham stimulation uses identical procedures, participant positioning, coil placement, session duration, and acoustic cues as active rTMS, but with the coil oriented perpendicular to the scalp to minimize effective cortical stimulation
Device: Sham repetitive transcranial magnetic stimulation
Sham rTMS is administered using the same procedures, participant positioning, coil placement, stimulation duration (20 minutes), and acoustic cues as the active stimulation protocol. To minimize effective cortical stimulation, the coil is oriented perpendicular to the scalp, producing minimal magnetic field penetration while preserving the characteristic clicking sound. Sham sessions follow the same schedule as active rTMS (once daily, five days per week, for four consecutive weeks; 20 sessions).
Other: Conventional motor rehabilitation
Participants receive standardized conventional motor rehabilitation for 60 minutes per day, five days per week, for four consecutive weeks. Each daily session includes three components: therapeutic exercise (approximately 20 minutes), physical therapy modalities (approximately 20 minutes), and occupational therapy/task-oriented functional training (approximately 20 minutes). The rehabilitation program is identical in content, intensity, and duration for both study arms.
Experimental: Intervention Group
Participants receive active low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with standardized conventional motor rehabilitation targeting both upper and lower limb function. Active rTMS targets the primary motor cortex (M1) representations relevant to the upper limb (hand area) and lower limb (leg area), with stimulation parameters delivered according to the predefined protocol.
Other: Conventional motor rehabilitation
Participants receive standardized conventional motor rehabilitation for 60 minutes per day, five days per week, for four consecutive weeks. Each daily session includes three components: therapeutic exercise (approximately 20 minutes), physical therapy modalities (approximately 20 minutes), and occupational therapy/task-oriented functional training (approximately 20 minutes). The rehabilitation program is identical in content, intensity, and duration for both study arms.
Device: Active repetitive transcranial magnetic stimulation

Active rTMS is delivered at low frequency (1 Hz), 1200 pulses per session, 20 minutes per session, once daily, five days per week, for four consecutive weeks (20 sessions). rTMS is administered immediately prior to the daily conventional rehabilitation session.

Upper limb target: Stimulation is applied to the M1 hand area using a figure-of-eight coil. The stimulation site is identified using standard localization methods (EEG 10-20 system landmarks and/or motor evoked potentials when available).

Lower limb target: Stimulation is applied to the M1 leg area located near the cranial midline using a Hesed coil, with localization based on midline landmarks (near Cz) and/or motor evoked potentials from lower limb muscles when available.

Stimulation intensity is set relative to the individual motor threshold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UL)
Time Frame: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
The Fugl-Meyer Assessment for Upper Extremity (FMA-UL) is a validated scale for evaluating motor impairment of the upper limb after stroke. Scores range from 0 to 66, with higher scores indicating better motor function.
Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in manual dexterity assessed by the Box and Block Test (BBT)
Time Frame: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
The Box and Block Test assesses gross manual dexterity by counting the number of blocks transferred within 60 seconds
Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
Change in functional mobility assessed by the Timed Up and Go test (TUG)
Time Frame: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
The Timed Up and Go test measures functional mobility and balance by recording the time required to stand up, walk, turn, and sit down
Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
Change in balance performance assessed by the Berg Balance Scale (BBS)
Time Frame: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
The Berg Balance Scale evaluates static and dynamic balance abilities, with scores ranging from 0 to 56
Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
Change in activities of daily living assessed by the modified Barthel Index (mBI)
Time Frame: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
The modified Barthel Index measures independence in activities of daily living, with higher scores indicating greater functional independence
Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
Change in quality of life assessed by the Stroke-Specific Quality of Life Scale (SS-QoL)
Time Frame: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up
The Stroke-Specific Quality of Life Scale assesses health-related quality of life across multiple domains in stroke survivors
Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

Collaborators and Investigators

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

Sponsor

Hanoi Medical University

Investigators

  • Principal Investigator: Loan Phan Thi Kieu, MD, MSc, Hanoi Medical University, Hanoi, Vietnam

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 (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VN-2025-rTMS-MOTOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including demographic information, baseline characteristics, intervention allocation, and outcome measures collected during the study, will be shared. All shared data will be fully anonymized and will not contain any information that could identify individual participants.

IPD Sharing Time Frame

Beginning 6 months after publication of the primary results and ending 5 years thereafter.

IPD Sharing Access Criteria

Data will be shared upon reasonable request from qualified researchers. Requests will be reviewed by the study investigators and require approval of a research proposal and a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

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