About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
High-Frequency, ipsilateral M1
DevicerTMS 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
DevicerTMS 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
DevicerTMS 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
DevicerTMS 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.
Treatment groups
Trial outcomes
Primary outcomes
Differences of Timed Up and Go Test (TUG)
Measurement for gait function.
Secondary outcomes
Differences of Timed Up and Go Test (TUG)
Measurement for gait function.
Differences of Timed Up and Go Test (TUG)
Measurement for gait function.
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
Measurement for gait and cognitive function.
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
Measurement for gait and cognitive function.
Sponsors and contacts
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Samsung Medical Center
Lead sponsor
National Research Foundation of Korea
Collaborator
Ministry of Food and Drug Safety, Korea
Collaborator
Seoul National University Hospital
Collaborator
Bucheon St. Mary's Hospital
Collaborator
Saint Vincent's Hospital, Korea
Collaborator
Severance Hospital
Collaborator
Kumoh National Institute of Technology
Collaborator
NEUROPHET
Collaborator