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

April 1, 2024 updated by: Won Hyuk Chang, Samsung Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: 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.
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.
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of Timed Up and Go Test (TUG)
Time Frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function.
From baseline T0 to Post-intervention T2 (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of Timed Up and Go Test (TUG)
Time Frame: From baseline T0 to During-intervention T1 (2 weeks)
Measurement for gait function.
From baseline T0 to During-intervention T1 (2 weeks)
Differences of Timed Up and Go Test (TUG)
Time Frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait function.
From baseline T0 to Follow-up T3 (2 months)
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.
From baseline T0 to During-intervention T1 (2 weeks)
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.
From baseline T0 to Post-intervention T2 (4 weeks)
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.
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
Differences of Digit span Test
Time Frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for cognitive function
From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Digit span Test
Time Frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for cognitive function
From baseline T0 to Follow-up T3 (2 months)
Differences of Trail making Test
Time Frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for cognitive function
From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Trail making Test
Time Frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for cognitive function
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)
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
From baseline T0 to Post-intervention T2 (4 weeks)
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
From baseline T0 to Follow-up T3 (2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Won Hyuk Chang, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-12-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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