Reduce freezing episodes during walking
- Trial ID
- NCT06630702
- Official Title
- Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease
- Goal
- Reduce freezing episodes during walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- National Taiwan University Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 5 participants
- Conditions
- Parkinson Disease, Freezing of Gait, Spinal Cord Stimulation
- Interventions
- SCS electrode stimulation 1, SCS electrode stimulation 2, SCS electrode stimulation 3
Summary For Families
The goal is to reduce freezing of gait in people with advanced Parkinson's who still respond to medication but keep having walking freezes that drugs do not stop. The approach is thoracic epidural spinal cord stimulation, which places electrodes in the upper back epidural space to send mild electrical pulses to spinal cord pathways that help coordinate walking. The stimulation aims to normalize gait-related signals so freezes happen less often or are shorter, it does not replace levodopa and can be used alongside your current medications. The trial is looking for adults 40 to 85 years old with Parkinson's for more than 5 years, clear drug response but persistent medication-resistant freezing, and no atypical Parkinsonism, major spinal problems, uncontrolled bleeding risk, or severe dementia.
Locations
- National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Hsinchu City, Taiwan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SCS electrode stimulation 1. The goal is to reduce freezing of gait in people with advanced Parkinson's who still respond to medication but keep having walking freezes that drugs do not stop. The approach is thoracic epidural spinal cord stimulation, which places electrodes in the upper back epidural space to send mild electrical pulses to spinal cord pathways that help coordinate walking. The stimulation aims to normalize gait-related signals so freezes happen less often or are shorter, it does not replace levodopa and can be used alongside your current medications. The trial is looking for adults 40 to 85 years old with Parkinson's for more than 5 years, clear drug response but persistent medication-resistant freezing, and no atypical Parkinsonism, major spinal problems, uncontrolled bleeding risk, or severe dementia.
- Who can participate?
- Participants must be between 40 Years and 85 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 3 years and 3 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.