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Parkinson's Disease and ParkinsonismNCT06350617

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

A study testing High-Frequency, ipsilateral M1, High-Frequency, bilateral M1 and High-Frequency, Lt. DLPFC in people with Parkinson's Disease and Parkinsonism, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Parkinson's Disease and Parkinsonism
What is being tested?
High-Frequency, ipsilateral M1, High-Frequency, bilateral M1 and High-Frequency, Lt. DLPFC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
20 Feb 2024to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with Parkinson's disease, diagnosed by the United Kingdom (UK) Parkinson's Disease Society Brain Bank Diagnostic Criteria,
  • Modified Hoehn and Yahr (H\&Y) scale, stage 2~4,
  • patients who can walk on flat surfaces without the need for a gait aid,
  • aged ≥50 years old,
  • patients willing to sign the informed consent.

Who cannot join

  • those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
  • 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
  • those with coexisting neurological conditions, such as spinal cord injury or Stroke,
  • those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
  • those with severe on-off phenomena or severe dyskinesia, deemed by the investigators to render participation in the study inappropriate.
  • those having contraindications to conduct an MRI study,
  • those who are pregnant or lactating,
  • patients who have refused to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Won Hyuk Chang, PhD contact

+82-2-3410-6068

wh.chang@samsung.com

South Korea1 site, 1 recruiting
  • Samsung Medical Center

    Seoul, 06351

    Won Hyuk Chang, PhD, +82-2-3410-6068, wh.chang@samsung.com

    Recruiting

Other trials in South Korea

About this study

Official title: Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease

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.

Read the detailed description

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.

Being tested
High-Frequency, ipsilateral M1, High-Frequency, bilateral M1, High-Frequency, Lt. DLPFC
Keywords
Parkinson's Disease, rTMS, Functional reserve
Medical subject headings
Parkinson Disease, Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Frequency, ipsilateral M1Device

    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 M1Device

    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. DLPFCDevice

    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 M1Device

    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 groups in NCT06350617
Study groupRoleWhat they receive
Ipsilateral High-FrequencyExperimentalPatients 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.
Receives: Device: High-Frequency, ipsilateral M1
Bilateral High-Frequency1Active comparatorPatients with motor priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.
Receives: Device: High-Frequency, bilateral M1
DLPFC High-FrequencyExperimentalPatients with cognitive priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over Lt. dorsolateral prefrontal cortex (DLPFC) will be applied.
Receives: Device: High-Frequency, Lt. DLPFC
Bilateral High-Frequency2Active comparatorPatients with cognitive priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.
Receives: Device: High-Frequency, bilateral M1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences of Timed Up and Go Test (TUG)

    Measurement for gait function.

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

Secondary outcomes (27)
  1. Differences of Timed Up and Go Test (TUG)

    Measurement for gait function.

    Measured: From baseline T0 to During-intervention T1 (2 weeks)

  2. Differences of Timed Up and Go Test (TUG)

    Measurement for gait function.

    Measured: From baseline T0 to Follow-up T3 (2 months)

  3. Differences of Timed Up and Go Test-Cognitive (TUG-Cog)

    Measurement for gait and cognitive function.

    Measured: From baseline T0 to During-intervention T1 (2 weeks)

  4. Differences of Timed Up and Go Test-Cognitive (TUG-Cog)

    Measurement for gait and cognitive function.

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  5. Differences of Timed Up and Go Test-Cognitive (TUG-Cog)

    Measurement for gait and cognitive function.

    Measured: From baseline T0 to Follow-up T3 (2 months)

  6. Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III

    Measurement for motor function of patients with Parkinson's disease. Score ranges from 0 to 132; higher score indicates more severity of disease status

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  7. Differences of MDS-UPDRS, Part III

    Measurement for motor function of patients with Parkinson's disease. Score ranges from 0 to 132; higher score indicates more severity of disease status

    Measured: From baseline T0 to Follow-up T3 (2 months)

  8. Differences of New Freezing of Gait Questionnaire (FoG-Q)

    Measurement for gait function of patients with Parkinson's disease Score ranges from 0 to 28; higher score indicates more severity of disease status

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  9. Differences of New Freezing of Gait Questionnaire (FoG-Q)

    Measurement for gait function of patients with Parkinson's disease Score ranges from 0 to 28; higher score indicates more severity of disease status

    Measured: From baseline T0 to Follow-up T3 (2 months)

  10. Differences of Digit span Test

    Measurement for cognitive function

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  11. Differences of Digit span Test

    Measurement for cognitive function

    Measured: From baseline T0 to Follow-up T3 (2 months)

  12. Differences of Trail making Test

    Measurement for cognitive function

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  13. Differences of Trail making Test

    Measurement for cognitive function

    Measured: From baseline T0 to Follow-up T3 (2 months)

  14. Differences of Gait lab parameter (Gait speed)

    Measurement for gait function. Gait speed (km/hr) will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  15. Differences of Gait lab parameter (Gait speed)

    Measurement for gait function. unit: km/hr Gait speed (km/hr) will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

  16. Differences of Gait lab parameter (Stride length)

    Measurement for gait function Stride length (m) will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  17. Differences of Gait lab parameter (Stride length)

    Measurement for gait function Stride length (m) will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

  18. Differences of Gait lab parameter (Step count)

    Measurement for gait function Step count will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  19. Differences of Gait lab parameter (Step count)

    Measurement for gait function Step count will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

  20. Differences of Gait lab parameter (Cadence)

    Measurement for gait function Cadence (step count/min) will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  21. Differences of Gait lab parameter (Cadence)

    Measurement for gait function Cadence (step count/min) will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

  22. Differences of Gait lab parameter (Swing ratio)

    Measurement for gait function Swing ratio (% of swing phase of 1 gait cycle) will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  23. Differences of Gait lab parameter (Swing ratio)

    Measurement for gait function Swing ratio (% of swing phase of 1 gait cycle) will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

  24. Differences of Gait lab parameter (Stride time)

    Measurement for gait function Stride time (unit- second, time from heel strike to next heel strike) will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  25. Differences of Gait lab parameter (Stride time)

    Measurement for gait function Stride time (unit- second, time from heel strike to next heel strike) will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

  26. Differences of Gait lab parameter (Pressure distribution)

    Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured

    Measured: From baseline T0 to Post-intervention T2 (4 weeks)

  27. Differences of Gait lab parameter (Pressure distribution)

    Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured

    Measured: From baseline T0 to Follow-up T3 (2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start20 Feb 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350617
Sponsor's protocol ID
2023-12-028
Status last verified
Apr 2026
First submitted
27 Feb 2024
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yun SJ, Lee HS, Kim DH, Im S, Yoo YJ, Kim NY, Lee J, Kim D, Park HY, Yoon MJ, Kim YS, Chang WH, Seo HG. Efficacy of personalized repetitive transcranial magnetic stimulation based on functional reserve to enhance ambulatory function in patients with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2024 Aug 16;25(1):543. doi: 10.1186/s13063-024-08385-2.

    PubMed 39152467

Questions about this trial

What is this clinical trial studying?

A study testing High-Frequency, ipsilateral M1, High-Frequency, bilateral M1 and High-Frequency, Lt. DLPFC in people with Parkinson's Disease and Parkinsonism, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Won Hyuk Chang, PhD (+82-2-3410-6068, wh.chang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences of Timed Up and Go Test (TUG) (time frame: From baseline T0 to Post-intervention T2 (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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