Reduce tremor using brain stimulation
- Trial ID
- NCT05752656
- Official Title
- Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
- Goal
- Reduce tremor using brain stimulation
- Status
- RECRUITING
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study Type
- OBSERVATIONAL
- Enrollment
- 100 participants
- Conditions
- Parkinson Disease
- Interventions
- Clinical examinations
Summary For Families
The goal is to track short- and long-term motor, cognitive, and behavioral effects after frameless deep brain stimulation in people with Parkinson's. Frameless DBS uses image-guided, frame-free surgery to place electrodes that deliver continuous electrical pulses to deep brain targets, which can reduce tremor, stiffness, and slowness and may allow lowering levodopa doses while sometimes affecting mood or thinking; researchers will follow patients with regular clinical examinations to see how these areas change over time. The study is enrolling adults 18 and older with idiopathic Parkinson's who are already judged suitable for DBS under standard CAPSIT-PD criteria, excluding only those unable to give informed consent.
Locations
- Flavia Torlizzi, Rome, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical examinations. The goal is to track short- and long-term motor, cognitive, and behavioral effects after frameless deep brain stimulation in people with Parkinson's. Frameless DBS uses image-guided, frame-free surgery to place electrodes that deliver continuous electrical pulses to deep brain targets, which can reduce tremor, stiffness, and slowness and may allow lowering levodopa doses while sometimes affecting mood or thinking; researchers will follow patients with regular clinical examinations to see how these areas change over time. The study is enrolling adults 18 and older with idiopathic Parkinson's who are already judged suitable for DBS under standard CAPSIT-PD criteria, excluding only those unable to give informed consent.
- Who can participate?
- Participants must be at least 18 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 1 year 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.