Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2025-09-30

Brief Summary

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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 patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease 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 patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

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Detailed Description

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rTMS treatment for patients with Parkinson's disease is traditionally based on stimulating the neural network of brain. The widely-used traditional rTMS treatment protocol involves high-frequency stimulation over the bilateral primary motor cortex (M1) to enhance motor and gait functions. However, concerns have arisen regarding the effect of rTMS on motor recovery in patients with Parkinson's disease. Although still subject to debate, a possible reason for the diverse results of rTMS applied 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 patient with Parkinson's disease.

Based on screening evaluations (Timed Up and Go Test (TUG), Timed Up and Go Dual Task-Cognitive (TUG-Cog)), investigators hypothesized that patients could be categorized into two groups: 1) priority in motor functional reserve, 2) priority in cognitive functional reserve. 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 high-frequency rTMS applied to the bilateral M1.

Conditions

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Parkinson's Disease and Parkinsonism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Ipsilateral High-Frequency

Patients with motor priority confirmed by TUG and TUG-Cog tests.

High-frequency (HF) rTMS over more affected primary motor cortex (M1) of lower extremity will be applied.

Group Type EXPERIMENTAL

High-Frequency, ipsilateral M1

Intervention Type 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 of lower extremity.

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Bilateral High-Frequency1

Patients with motor priority confirmed by TUG and TUG-Cog tests.

High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.

Group Type ACTIVE_COMPARATOR

High-Frequency, bilateral M1

Intervention Type 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: bilateral primary motor cortex of lower extremity.

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

DLPFC High-Frequency

Patients with cognitive priority confirmed by TUG and TUG-Cog tests.

High-frequency (HF) rTMS over Lt. dorsolateral prefrontal cortex (DLPFC) will be applied.

Group Type EXPERIMENTAL

High-Frequency, Lt. DLPFC

Intervention Type 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: Lt. DLPFC

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Bilateral High-Frequency2

Patients with cognitive priority confirmed by TUG and TUG-Cog tests.

High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.

Group Type ACTIVE_COMPARATOR

High-Frequency, bilateral M1

Intervention Type 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: bilateral primary motor cortex of lower extremity.

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Interventions

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High-Frequency, ipsilateral M1

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 of lower extremity.

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Intervention Type DEVICE

High-Frequency, bilateral M1

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: bilateral primary motor cortex of lower extremity.

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Intervention Type DEVICE

High-Frequency, Lt. DLPFC

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: Lt. DLPFC

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Intervention Type DEVICE

High-Frequency, bilateral M1

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: bilateral primary motor cortex of lower extremity.

Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions.

Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. patients with Parkinson's disease, diagnosed by the United Kingdom (UK) Parkinson's Disease Society Brain Bank Diagnostic Criteria,
2. Modified Hoehn and Yahr (H\&Y) scale, stage 2\~4,
3. patients who can walk on flat surfaces without the need for a gait aid,
4. aged ≥50 years old,
5. 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 cognitive impairment, confirmed through the Montreal Cognitive Assessment (MoCA) test as follows: \< 7 points: Illiterate \< 13 points: Education duration 0.5-3 years \< 16 points: Education duration 4-6 years \< 19 points: Education duration 7-9 years \< 20 points: Education duration 10 years or more
3. those with coexisting neurological conditions, such as spinal cord injury or Stroke,
4. those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
5. those with severe on-off phenomena or severe dyskinesia, deemed by the investigators to render participation in the study inappropriate.
6. those having contraindications to conduct an MRI study,
7. those who are pregnant or lactating,
8. patients who have refused to participate in this study.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No