RecruitingNot ApplicableNCT06350617

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

Sponsor

Samsung Medical Center

Enrollment

60 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson's Disease and Parkinsonism

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study uses a personalized form of repetitive transcranial magnetic stimulation (rTMS — a non-invasive brain stimulation technique using magnetic pulses) tailored to each patient's brain activity to improve walking ability in people with Parkinson's disease. **You may be eligible if...** - You have been diagnosed with Parkinson's disease according to established medical criteria - Your Parkinson's is rated as stage 2 to 4 on the Hoehn and Yahr scale (meaning moderate to moderately severe) - You are able to walk on flat surfaces without a walking aid - You are 50 years or older - You are willing to sign the informed consent form **You may NOT be eligible if...** - You have epilepsy or a history of seizures - You have a metal implant in your head or have had previous brain surgery - You have significant cognitive impairment - You have other serious neurological conditions - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-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.

DEVICEHigh-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.

DEVICEHigh-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.

DEVICEHigh-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.