NCT06350617 Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients
| NCT ID | NCT06350617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Parkinson's Disease and Parkinsonism |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-20 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Won Hyuk Chang, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT06350617 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Parkinson's Disease and Parkinsonism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06350617 currently recruiting?
Yes, NCT06350617 is actively recruiting participants. Contact the research team at wh.chang@samsung.com for enrollment information.
Where is the NCT06350617 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06350617 clinical trial?
NCT06350617 is sponsored by Samsung Medical Center. The principal investigator is Won Hyuk Chang, PhD at Samsung Medical Center. The trial plans to enroll 60 participants.
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