Personalized stimulation to improve walking
- Trial ID
- NCT06350617
- Official Title
- Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
- Goal
- Personalized stimulation to improve walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Samsung Medical Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease and Parkinsonism
- Interventions
- High-Frequency, ipsilateral M1, High-Frequency, bilateral M1, High-Frequency, Lt. DLPFC, High-Frequency, bilateral M1
Summary For Families
The goal is to help people with Parkinson's walk better by boosting the brain networks that support gait and balance. The approach uses personalized, high-frequency repetitive transcranial magnetic stimulation, targeting the motor cortex (one side or both) and sometimes the left dorsolateral prefrontal cortex, with the protocol tuned to each person’s functional reserve so the most responsive brain areas get stronger magnetic pulses; the pulses increase excitability in those circuits, they are noninvasive, and they do not replace levodopa but may make motor circuits more responsive to medications. The trial is looking for adults aged 50 and up with Parkinson’s (UK Brain Bank criteria) in Hoehn and Yahr stages 2 to 4 who can walk on flat ground without a gait aid. People with epilepsy or metal in the head, significant cognitive impairment by MoCA thresholds, other major neurological or psychiatric disorders, severe on-off swings or dyskinesia, MRI contraindications, or pregnancy are excluded.
Locations
- Samsung Medical Center, Seoul, South Korea
Frequently Asked Questions
- What is this trial testing?
- This trial is studying High-Frequency, ipsilateral M1. The goal is to help people with Parkinson's walk better by boosting the brain networks that support gait and balance. The approach uses personalized, high-frequency repetitive transcranial magnetic stimulation, targeting the motor cortex (one side or both) and sometimes the left dorsolateral prefrontal cortex, with the protocol tuned to each person’s functional reserve so the most responsive brain areas get stronger magnetic pulses; the pulses increase excitability in those circuits, they are noninvasive, and they do not replace levodopa but may make motor circuits more responsive to medications. The trial is looking for adults aged 50 and up with Parkinson’s (UK Brain Bank criteria) in Hoehn and Yahr stages 2 to 4 who can walk on flat ground without a gait aid. People with epilepsy or metal in the head, significant cognitive impairment by MoCA thresholds, other major neurological or psychiatric disorders, severe on-off swings or dyskinesia, MRI contraindications, or pregnancy are excluded.
- Who can participate?
- Participants must be at least 50 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 7 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.