High-Frequency, ipsilateral M1 for Parkinson's (NCT06350617)
Personalized brain stimulation improves 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 brain stimulation improves 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
Researchers want to see if tailoring repetitive transcranial magnetic stimulation, a therapy that uses magnetic pulses to stimulate brain networks, to each person’s “functional reserve” can improve walking and movement more than the usual high-frequency stimulation over both sides of the primary motor area. They group people by simple walking tests, including a version with a thinking task, into those with a motor-strength profile or a thinking-strength profile, then randomly give either the personalized stimulation target or the conventional bilateral motor-area stimulation to compare results. The trial seeks people aged 50 or older with Parkinson’s at stage 2 to 4 who can walk on flat ground without a walking aid and who do not have major cognitive impairment, epilepsy or metal in the head, other major neurological or psychiatric conditions, severe movement fluctuations or severe involuntary movements, pregnancy or any reason they cannot have magnetic stimulation or an MRI.
Locations
- Samsung Medical Center, Seoul, South Korea
Frequently Asked Questions
- What is this trial testing?
- This trial is studying High-Frequency, ipsilateral M1. Researchers want to see if tailoring repetitive transcranial magnetic stimulation, a therapy that uses magnetic pulses to stimulate brain networks, to each person’s “functional reserve” can improve walking and movement more than the usual high-frequency stimulation over both sides of the primary motor area. They group people by simple walking tests, including a version with a thinking task, into those with a motor-strength profile or a thinking-strength profile, then randomly give either the personalized stimulation target or the conventional bilateral motor-area stimulation to compare results. The trial seeks people aged 50 or older with Parkinson’s at stage 2 to 4 who can walk on flat ground without a walking aid and who do not have major cognitive impairment, epilepsy or metal in the head, other major neurological or psychiatric conditions, severe movement fluctuations or severe involuntary movements, pregnancy or any reason they cannot have magnetic stimulation or an MRI.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 7 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.