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

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: cTBS1; Device: High-Frequency3; Device: High-Frequency2; Device: High-Frequency1; Device: cTBS3; Device: cTBS2

• Registration Number: NCT06270238
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

rTMS treatment for patients with stroke is traditionally based on interhemispheric interactions. The widely-used traditional rTMS treatment protocol involves inhibitory low-frequency or continuous theta burst stimulation (cTBS) applied over the contralesional hemisphere and excitatory high-frequency stimulation over the ipsilesional hemisphere. However, concerns have arisen regarding the effect of rTMS on motor recovery in stroke patients. Although still subject to debate, a possible reason for the diverse results of rTMS applied to stroke patients is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery.

Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each hemiplegic stroke patient.

Based on screening evaluations (TMS-induced motor evoked potential (MEP), diffusion tensor imaging (DTI), MRI), investigators hypothesized that patients could be categorized into three groups: 1) preserved ipsilateral corticospinal tract, 2) preserved ipsilateral alternative corticospinal tract, and 3) no ipsilateral corticospinal tract preserved. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional inhibitory rTMS applied to the contralesional primary motor cortex.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-13
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cTBS1	cTBS1	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.
High-Frequency3	High-Frequency3	Absent responses in all ipsilateral corticospinal tract. High-frequency rTMS over contralateral primary motor cortex will be applied.
High-Frequency2	High-Frequency2	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.
High-Frequency1	High-Frequency1	Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract. High-frequency rTMS over ipsilateral primary motor cortex will be applied.
cTBS3	cTBS3	Absent responses in all ipsilateral corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.
cTBS2	cTBS2	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.

Primary Outcome Measures

Name	Time	Method
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)	From baseline T0 to Post-intervention T2 (2 weeks)	Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better

Secondary Outcome Measures

Name	Time	Method
Differences of Fugl-Meyer Assessment score (FMA)	From baseline T0 to Follow-up T3 (2 months)	Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better
Differences of Action Research Arm Test (ARAT)	From baseline T0 to Follow-up T3 (2 months)	Measurement to assess upper extremity performance (coordination, dexterity and functioning).; Minimum: 0, Maximum: 57. Higher score means a better.
Differences of Jebsen-Taylor hand function test	From baseline T0 to Follow-up T3 (2 months)	Measurement of fine and gross motor hand function using simulated activities of daily living.; Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)	From baseline T0 to Follow-up T3 (2 months)	Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Differences of Hand grip strength test	From baseline T0 to Follow-up T3 (2 months)	Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.
Differences of Box and block test	From baseline T0 to Follow-up T3 (2 months)	Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)	From baseline T0 to Follow-up T3 (2 months)	Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better
Differences of Functional Ambulation Category (FAC)	From baseline T0 to Follow-up T3 (2 months)	Measurement for gait function. Minimum: 0, Maximum: 5. Higher score means a better.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of