Magnetic stimulation slows Parkinson progression
- Trial ID
- NCT06002581
- Official Title
- Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
- Goal
- Magnetic stimulation slows Parkinson progression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study Type
- INTERVENTIONAL
- Enrollment
- 56 participants
- Conditions
- Parkinson's Disease
- Interventions
- rTMS real stimulation stage1, rTMS shame stimulation stage1, rTMS real stimulation stage 2
Summary For Families
Goal: The trial aims to slow Parkinson's progression by boosting deep slow-wave sleep, which may help the brain clear toxic proteins and support repair and plasticity linked to symptom worsening. Approach: It uses repetitive transcranial magnetic stimulation, noninvasive magnetic pulses to targeted brain regions to increase slow-wave non-REM sleep; rTMS does not change levodopa itself, so participants keep a stable levodopa dose while researchers test whether better slow-wave sleep affects symptoms or disease course. Eligibility: The study is enrolling right-handed Chinese Han adults aged 50 to 80 with clinically probable or definite PD at Hoehn-Yahr stages 1,4, on a stable levodopa regimen, without major cognitive impairment, prior brain surgery or TMS, significant sleep apnea or other listed contraindications.
Locations
- Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying rTMS real stimulation stage1. Goal: The trial aims to slow Parkinson's progression by boosting deep slow-wave sleep, which may help the brain clear toxic proteins and support repair and plasticity linked to symptom worsening. Approach: It uses repetitive transcranial magnetic stimulation, noninvasive magnetic pulses to targeted brain regions to increase slow-wave non-REM sleep; rTMS does not change levodopa itself, so participants keep a stable levodopa dose while researchers test whether better slow-wave sleep affects symptoms or disease course. Eligibility: The study is enrolling right-handed Chinese Han adults aged 50 to 80 with clinically probable or definite PD at Hoehn-Yahr stages 1,4, on a stable levodopa regimen, without major cognitive impairment, prior brain surgery or TMS, significant sleep apnea or other listed contraindications.
- Who can participate?
- Participants must be between 50 Years and 80 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 11 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.