Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation Improves Motor and Functional Outcomes After Ischemic Stroke

NCT07369648 | Not Yet Recruiting

• 1 other identifier: VN-2025-rTMS-MOTOR
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Ischemic Stroke; Hemiplegia; Motor Function Impairment

Keywords

Repetitive Transcranial Magnetic Stimulation; rTMS; Motor Recovery; Post-Stroke Hemiplegia; Neurorehabilitation; Motor function

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Change in manual dexterity assessed by the Box and Block Test (BBT)

  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)

  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)

  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)

  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)

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

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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; Other: Conventional motor rehabilitation

Intervention Group

EXPERIMENTAL

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.

Device: Active repetitive transcranial magnetic stimulation; Other: Conventional motor rehabilitation

Interventions

Active repetitive transcranial magnetic stimulation DEVICE

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.

Intervention Group

Sham repetitive transcranial magnetic stimulation DEVICE

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).

Control Group

Conventional motor rehabilitation OTHER

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

MeSH Terms

Conditions

Ischemic Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loan Phan Thi Kieu, MD, MSc

  Hanoi Medical University, Hanoi, Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loan Phan Thi Kieu, MD, MSc

CONTACT

+84 975309081; phanthikieuloan@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded using sham repetitive transcranial magnetic stimulation, in which the procedure, coil positioning, stimulation duration, and acoustic cues are identical to the active intervention, while the coil is positioned perpendicular to minimize cortical stimulation. Outcome assessors are blinded to group allocation and are not involved in participant recruitment, randomization, or intervention delivery. Assessments are conducted in a separate room and at different time points from the intervention sessions. In case of unintended unblinding, the assessor is replaced and the incident is documented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
• 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.