Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation Improves Motor and Functional Outcomes After Ischemic Stroke: A Randomized Sham-Controlled Trial (rTMS-MOTOR)

Hanoi Medical University

Status: Not yet enrolling

Conditions: Ischemic Stroke; Motor Function Impairment; Hemiplegia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07369648

VN-2025-rTMS-MOTOR

Details and patient eligibility

About

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.

Full 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 double-cone 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Conventional motor rehabilitation

Device: Sham repetitive transcranial magnetic stimulation

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Conventional motor rehabilitation

Device: Active repetitive transcranial magnetic stimulation