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

Samsung Medical Center

Status: Enrolling

Conditions: Stroke

Treatments: Device: High-Frequency2; Device: High-Frequency3; Device: cTBS2; Device: cTBS3; Device: High-Frequency1; Device: cTBS1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06270238

2023-11-164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 6 patient groups

High-Frequency1

Experimental group

Description:

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

Treatment:

Device: High-Frequency1

cTBS1

Active Comparator group

Description:

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.

Treatment:

Device: cTBS1

High-Frequency2

Experimental group

Description:

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.

Treatment:

Device: High-Frequency2

cTBS2

Active Comparator group

Description:

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.

Treatment:

Device: cTBS2

High-Frequency3

Experimental group

Description:

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

Treatment:

Device: High-Frequency3

cTBS3

Active Comparator group

Description:

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

Treatment:

Device: cTBS3