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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Won Hyuk Chang, PhD
wh.chang@samsung.com
+82-2-3410-6068
Backup
Ho Seok Lee, PhD
hoseok89.lee@samsung.com
+82-2-3410-2810
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 60
Treatments
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Seoul National University Hospital, National Research Foundation of Korea, Saint Vincent's Hospital, Korea, NEUROPHET, Bucheon St. Mary's Hospital, Severance Hospital, Kumoh National Institute of Technology, Ministry of Food and Drug Safety, Korea
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov