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Clinical Trials in South Korea / NCT06350617
Recruiting Not applicable

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

NCT06350617 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2024-02-20
Last updated
2026-04-28

Condition(s) studied

Parkinson's Disease and Parkinsonism

Investigational drug(s) / intervention(s)

High-Frequency, ipsilateral M1High-Frequency, bilateral M1High-Frequency, Lt. DLPFCHigh-Frequency, bilateral M1

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.

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.

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.

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.

Study 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 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Differences of Timed Up and Go Test (TUG) — From baseline T0 to Post-intervention T2 (4 weeks)
    Measurement for gait function.

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06350617 on ClinicalTrials.gov ↗ ← All trials in South Korea