Personalized rTMS therapy to improve walking in Parkinson's patients
Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
This study is testing whether personalized brain stimulation can help improve walking in people with Parkinson's disease better than standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06350617 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of personalized repetitive transcranial magnetic stimulation (rTMS) protocols tailored to the functional reserve of patients with Parkinson's disease. By categorizing patients based on their motor and cognitive functional reserves, the study aims to compare the efficacy of these personalized protocols against conventional high-frequency rTMS applied to the primary motor cortex. The approach seeks to enhance motor function recovery by addressing the unique needs of each patient rather than using a one-size-fits-all method. Participants will be randomly assigned to different treatment groups to evaluate the outcomes of this tailored therapy.
Who should consider this trial
Good fit: Ideal candidates include patients aged 50 and older with Parkinson's disease who can walk without assistance and are in stages 2 to 4 of the Modified Hoehn and Yahr scale.
Not a fit: Patients with significant cognitive impairment or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for improving mobility in patients with Parkinson's disease.
How similar studies have performed: While traditional rTMS has been widely studied, this personalized approach based on functional reserve is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Won Hyuk Chang, PhD — Samsung Medical Center
- Study coordinator: Won Hyuk Chang, PhD
- Email: wh.chang@samsung.com
- Phone: +82-2-3410-6068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.