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

Stroke Clinical Trial

Official title:

Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients: A Multi Center, Randomized, Single Blind, Parallel Group Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270238
• Other study ID #: 2023-11-164
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Samsung Medical Center
• Contact: Won Hyuk Chang, PhD
• Phone: 82-2-3410-6068
• Email: wh.chang[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• High-Frequency1
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.
• cTBS1
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.
• High-Frequency2
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.
• cTBS2
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.
• High-Frequency3
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.
• cTBS3
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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (9)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 During-intervention T1 (1 week)
Secondary	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 Follow-up T3 (2 months)
Secondary	Differences of Fugl-Meyer Assessment score (FMA)	Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Fugl-Meyer Assessment score (FMA)	Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Fugl-Meyer Assessment score (FMA)	Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better	From baseline T0 to Follow-up T3 (2 months)
Secondary	Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)	Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)	Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)	Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better	From baseline T0 to Follow-up T3 (2 months)
Secondary	Differences of Box and block test	Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Box and block test	Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Box and block test	Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.	From baseline T0 to Follow-up T3 (2 months)
Secondary	Differences of Functional Ambulation Category (FAC)	Measurement for gait function. Minimum: 0, Maximum: 5 Higher score means a better.	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Functional Ambulation Category (FAC)	Measurement for gait function. Minimum: 0, Maximum: 5 Higher score means a better.	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Functional Ambulation Category (FAC)	Measurement for gait function. Minimum: 0, Maximum: 5. Higher score means a better.	From baseline T0 to Follow-up T3 (2 months)
Secondary	Differences of Action Research Arm Test (ARAT)	Measurement to assess upper extremity performance (coordination, dexterity and functioning).; Minimum: 0, Maximum: 57. Higher score means a better.	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Action Research Arm Test (ARAT)	Measurement to assess upper extremity performance (coordination, dexterity and functioning).; Minimum: 0, Maximum: 57. Higher score means a better.	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Action Research Arm Test (ARAT)	Measurement to assess upper extremity performance (coordination, dexterity and functioning).; Minimum: 0, Maximum: 57. Higher score means a better.	From baseline T0 to Follow-up T3 (2 months)
Secondary	Differences of Jebsen-Taylor hand function test	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.	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Jebsen-Taylor hand function test	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.	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Jebsen-Taylor hand function test	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.	From baseline T0 to Follow-up T3 (2 months)
Secondary	Differences of Hand grip strength test	Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.	From baseline T0 to During-intervention T1 (1 week)
Secondary	Differences of Hand grip strength test	Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.	From baseline T0 to Post-intervention T2 (2 weeks)
Secondary	Differences of Hand grip strength test	Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.	From baseline T0 to Follow-up T3 (2 months)