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NCT Number: NCT06350617

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

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

High-Frequency, ipsilateral M1

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.

High-Frequency, bilateral M1

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.

High-Frequency, Lt. DLPFC

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.

Primary outcomes

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

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

    Measurement for gait function.

Secondary outcomes

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

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

    Measurement for gait function.

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

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

    Measurement for gait function.

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

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

    Measurement for gait and cognitive function.

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

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

    Measurement for gait and cognitive function.

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

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

    Measurement for gait and cognitive function.

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

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

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

  7. Differences of MDS-UPDRS, Part III

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

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

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

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

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

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

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

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

  10. Differences of Digit span Test

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

    Measurement for cognitive function

  11. Differences of Digit span Test

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

    Measurement for cognitive function

  12. Differences of Trail making Test

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

    Measurement for cognitive function

  13. Differences of Trail making Test

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

    Measurement for cognitive function

  14. Differences of Gait lab parameter (Gait speed)

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

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

  15. Differences of Gait lab parameter (Gait speed)

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

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

  16. Differences of Gait lab parameter (Stride length)

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

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

  17. Differences of Gait lab parameter (Stride length)

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

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

  18. Differences of Gait lab parameter (Step count)

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

    Measurement for gait function Step count will be measured

  19. Differences of Gait lab parameter (Step count)

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

    Measurement for gait function Step count will be measured

  20. Differences of Gait lab parameter (Cadence)

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

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

  21. Differences of Gait lab parameter (Cadence)

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

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

  22. Differences of Gait lab parameter (Swing ratio)

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

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

  23. Differences of Gait lab parameter (Swing ratio)

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

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

  24. Differences of Gait lab parameter (Stride time)

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

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

  25. Differences of Gait lab parameter (Stride time)

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

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

  26. Differences of Gait lab parameter (Pressure distribution)

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

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

  27. Differences of Gait lab parameter (Pressure distribution)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ho Seok Lee, PhD

CONTACT

[email protected]

+82-2-3410-2810

Won Hyuk Chang, PhD

CONTACT

[email protected]

+82-2-3410-6068

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Bucheon St. Mary's Hospital
  • Kumoh National Institute of Technology
  • Ministry of Food and Drug Safety, Korea
  • NEUROPHET
  • National Research Foundation of Korea
  • Saint Vincent's Hospital, Korea
  • Seoul National University Hospital
  • Severance Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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