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Ischemic StrokerTMS-MOTORNCT07369648

Repetitive Transcranial Magnetic Stimulation for Motor Recovery After Ischemic Stroke (rTMS-MOTOR)

A study testing Active repetitive transcranial magnetic stimulation and Conventional motor rehabilitation in people with Ischemic Stroke and Hemiplegia, run by Hanoi Medical University at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Active repetitive transcranial magnetic stimulation and Conventional motor rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteVietnam
Study dates
1 Feb 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Loan Phan Thi Kieu, MD, MSc contact

+84 975309081

phanthikieuloan@hmu.edu.vn

Vietnam1 site, 1 recruiting
  • Hanoi Rehabilitation Hospital

    Hanoi

    Loan Phan Thi Kieu, MD. MSc, +84 975309081, phanthikieuloan@hmu.edu.vn

    Loan Phan Thi Kieu, MD, MSc

    Recruiting

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Being tested
Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation, Conventional motor rehabilitation
Keywords
Repetitive Transcranial Magnetic Stimulation, rTMS, Motor Recovery, Post-Stroke Hemiplegia, Neurorehabilitation, Motor function
Medical subject headings
Ischemic Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active repetitive transcranial magnetic stimulationDevice

    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.

  • Sham repetitive transcranial magnetic stimulationDevice

    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).

  • Conventional motor rehabilitationOther

    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.

Study groups in NCT07369648
Study groupRoleWhat they receive
Control GroupPlacebo comparatorParticipants 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
Receives: Device: Sham repetitive transcranial magnetic stimulation; Other: Conventional motor rehabilitation
Intervention GroupExperimentalParticipants 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.
Receives: Device: Active repetitive transcranial magnetic stimulation; Other: Conventional motor rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UL)

    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.

    Measured: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

Secondary outcomes (5)
  1. Change in manual dexterity assessed by the Box and Block Test (BBT)

    The Box and Block Test assesses gross manual dexterity by counting the number of blocks transferred within 60 seconds

    Measured: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

  2. Change in functional mobility assessed by the Timed Up and Go test (TUG)

    The Timed Up and Go test measures functional mobility and balance by recording the time required to stand up, walk, turn, and sit down

    Measured: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

  3. Change in balance performance assessed by the Berg Balance Scale (BBS)

    The Berg Balance Scale evaluates static and dynamic balance abilities, with scores ranging from 0 to 56

    Measured: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

  4. Change in activities of daily living assessed by the modified Barthel Index (mBI)

    The modified Barthel Index measures independence in activities of daily living, with higher scores indicating greater functional independence

    Measured: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

  5. Change in quality of life assessed by the Stroke-Specific Quality of Life Scale (SS-QoL)

    The Stroke-Specific Quality of Life Scale assesses health-related quality of life across multiple domains in stroke survivors

    Measured: Baseline, immediately after the 4-week intervention period, and at 3-month and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are allocated into two parallel groups. The intervention group receives active repetitive transcranial magnetic stimulation combined with conventional motor rehabilitation, while the control group receives sham repetitive transcranial magnetic stimulation combined with the same conventional motor rehabilitation program. Participants are followed longitudinally, with outcome assessments conducted at baseline, immediately after completion of the intervention period, and at 3-month and 6-month follow-up assessments.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07369648
Sponsor's protocol ID
VN-2025-rTMS-MOTOR
Acronym
rTMS-MOTOR
Status last verified
Sep 2026
First submitted
18 Jan 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Active repetitive transcranial magnetic stimulation and Conventional motor rehabilitation in people with Ischemic Stroke and Hemiplegia, run by Hanoi Medical University at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Loan Phan Thi Kieu, MD, MSc (+84 975309081, phanthikieuloan@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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