Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients

NCT06270238 | Recruiting

• 1 other identifier: 2023-11-164
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

Conditions

Stroke

Keywords

Stroke; rTMS; Functional reserve

Outcome Measures

Primary Outcomes (1)

• Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)

  Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better

  From baseline T0 to Post-intervention T2 (2 weeks)

Secondary Outcomes (23)

• Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)

  From baseline T0 to During-intervention T1 (1 week)

• Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)

  From baseline T0 to Follow-up T3 (2 months)

• Differences of Fugl-Meyer Assessment score (FMA)

  From baseline T0 to During-intervention T1 (1 week)

• Differences of Fugl-Meyer Assessment score (FMA)

  From baseline T0 to Post-intervention T2 (2 weeks)

• Differences of Fugl-Meyer Assessment score (FMA)

  From baseline T0 to Follow-up T3 (2 months)

Study Arms (6)

High-Frequency1

EXPERIMENTAL

Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract. High-frequency rTMS over ipsilateral primary motor cortex will be applied.

Device: High-Frequency1

cTBS1

ACTIVE COMPARATOR

Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.

Device: cTBS1

High-Frequency2

EXPERIMENTAL

Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract. High-frequency rTMS over ipsilateral premotor cortex will be applied.

Device: High-Frequency2

cTBS2

ACTIVE COMPARATOR

Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.

Device: cTBS2

High-Frequency3

EXPERIMENTAL

Absent responses in all ipsilateral corticospinal tract. High-frequency rTMS over contralateral primary motor cortex will be applied.

Device: High-Frequency3

cTBS3

ACTIVE COMPARATOR

Absent responses in all ipsilateral corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.

Device: cTBS3

Interventions

High-Frequency1 DEVICE

rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

High-Frequency1

cTBS1 DEVICE

rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

cTBS1

High-Frequency2 DEVICE

rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral premotor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

High-Frequency2

cTBS2 DEVICE

rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

cTBS2

High-Frequency3 DEVICE

rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

High-Frequency3

cTBS3 DEVICE

rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

cTBS3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,
• FMA score of the upper extremity ≤42,
• adequate language and cognitive function to perform at least a 1-step obey-command,
• pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
• aged ≥19 years old,
• patients willing to sign the informed consent.

You may not qualify if:

• those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
• those with progressive of hemodynamically unstable medical conditions,
• those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
• those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
• those having contraindications to conduct an MRI study,
• those who are pregnant or lactating ,
• patients who have refused to participate in this study.

Sponsors & Collaborators

• National Research Foundation of Korea: collaborator
• Samsung Medical Center: lead
• Ministry of Food and Drug Safety, Korea: collaborator
• Seoul National University Hospital: collaborator
• Bucheon St. Mary's Hospital: collaborator
• Saint Vincent's Hospital, Korea: collaborator
• Severance Hospital: collaborator
• Kumoh National Institute of Technology: collaborator
• NEUROPHET: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (1)

• Lee HS, Kim DH, Seo HG, Im S, Yoo YJ, Kim NY, Lee J, Kim D, Park HY, Yoon MJ, Kim YS, Kim H, Chang WH. Efficacy of personalized rTMS to enhance upper limb function in subacute stroke patients: a protocol for a multi-center, randomized controlled study. Front Neurol. 2024 Jul 3;15:1427142. doi: 10.3389/fneur.2024.1427142. eCollection 2024.

  PMID: 39022726 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Won Hyuk Chang, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Hyuk Chang, PhD

CONTACT

82-2-3410-6068; wh.chang@samsung.com

Ho Seok Lee, PhD

CONTACT

82-2-3410-2810; hoseok89.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)