Clinical trial NCT06270238: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
rTMS
Functional reserve
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: Ministry of Food and Drug Safety, Korea
name: Seoul National University Hospital
name: Bucheon St. Mary's Hospital
name: Saint Vincent's Hospital, Korea
name: Severance Hospital
name: Kumoh National Institute of Technology
name: NEUROPHET
First posted: 2024-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
Secondary outcomes:
measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Fugl-Meyer Assessment score (FMA)
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Fugl-Meyer Assessment score (FMA)
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Fugl-Meyer Assessment score (FMA)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Box and block test
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Box and block test
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Box and block test
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Functional Ambulation Category (FAC)
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Functional Ambulation Category (FAC)
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Functional Ambulation Category (FAC)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Action Research Arm Test (ARAT)
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Action Research Arm Test (ARAT)
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Action Research Arm Test (ARAT)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Jebsen-Taylor hand function test
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Jebsen-Taylor hand function test
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Jebsen-Taylor hand function test
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Hand grip strength test
timeFrame: From baseline T0 to During-intervention T1 (1 week)
measure: Differences of Hand grip strength test
timeFrame: From baseline T0 to Post-intervention T2 (2 weeks)
measure: Differences of Hand grip strength test
timeFrame: From baseline T0 to Follow-up T3 (2 months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Hyuk Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: