Clinical examinations for Parkinson's (NCT05752656)
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?
- 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 1 year and 11 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Study assessments are at baseline (before surgery) and one year after surgery.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.