Ischemic Stroke, Hemiplegia, Motor Function Impairment
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, rTMS, Motor Recovery, Post-Stroke Hemiplegia, Neurorehabilitation, Motor function
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.
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.
Interventions
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.
DEVICESham 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).
OTHERConventional 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.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The Box and Block Test assesses gross manual dexterity by counting the number of blocks transferred within 60 seconds |
| 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 | The Timed Up and Go test measures functional mobility and balance by recording the time required to stand up, walk, turn, and sit down |
| 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 | The Berg Balance Scale evaluates static and dynamic balance abilities, with scores ranging from 0 to 56 |
| 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 | The modified Barthel Index measures independence in activities of daily living, with higher scores indicating greater functional independence |
| 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 | The Stroke-Specific Quality of Life Scale assesses health-related quality of life across multiple domains in stroke survivors |
Contacts
CONTACTLoan Phan Thi Kieu, MD, MSc
PRINCIPAL_INVESTIGATORLoan Phan Thi Kieu, MD, MSc
Hanoi Medical University, Hanoi, Vietnam
Outcome results
None listed