Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients
Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2024
CompletedFirst Submitted
Initial submission to the registry
February 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
April 28, 2026
April 1, 2026
2.6 years
February 27, 2024
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences of Timed Up and Go Test (TUG)
Measurement for gait function.
From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Outcomes (27)
Differences of Timed Up and Go Test (TUG)
From baseline T0 to During-intervention T1 (2 weeks)
Differences of Timed Up and Go Test (TUG)
From baseline T0 to Follow-up T3 (2 months)
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
From baseline T0 to During-intervention T1 (2 weeks)
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
From baseline T0 to Follow-up T3 (2 months)
- +22 more secondary outcomes
Study Arms (4)
Ipsilateral High-Frequency
EXPERIMENTALPatients 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.
Bilateral High-Frequency1
ACTIVE COMPARATORPatients with motor priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.
DLPFC High-Frequency
EXPERIMENTALPatients with cognitive priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over Lt. dorsolateral prefrontal cortex (DLPFC) will be applied.
Bilateral High-Frequency2
ACTIVE COMPARATORPatients with cognitive priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- National Research Foundation of Koreacollaborator
- Ministry of Food and Drug Safety, Koreacollaborator
- Seoul National University Hospitalcollaborator
- Bucheon St. Mary's Hospitalcollaborator
- Saint Vincent's Hospital, Koreacollaborator
- Severance Hospitalcollaborator
- Kumoh National Institute of Technologycollaborator
- NEUROPHETcollaborator
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
Related Publications (1)
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.
PMID: 39152467DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won Hyuk Chang, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2024
First Posted
April 5, 2024
Study Start
February 20, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share