Clinical examinations and clinical… for Parkinson's (NCT06329726)
How brain stimulation affects thinking
- Trial ID
- NCT06329726
- Official Title
- Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
- Goal
- How brain stimulation affects thinking
- Status
- RECRUITING
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study Type
- OBSERVATIONAL
- Enrollment
- 52 participants
- Conditions
- Parkinson Disease
- Interventions
- Clinical examinations and clinical scales administration
Summary For Families
The goal is to see how long-term deep brain stimulation of the subthalamic nucleus affects thinking, mood, and behavior in people with Parkinson's disease. Participants get a first assessment and then yearly tests, questionnaires, and clinical rating scales for five years, and researchers will compare people who had deep brain stimulation with those receiving the best available medical treatment. The trial enrolls men and women aged 18 to 70 who are either candidates for deep brain stimulation of the subthalamic nucleus or are on best medical therapy, and it excludes anyone who cannot complete the assessments.
Locations
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Lombardy, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical examinations and clinical scales administration. The goal is to see how long-term deep brain stimulation of the subthalamic nucleus affects thinking, mood, and behavior in people with Parkinson's disease. Participants get a first assessment and then yearly tests, questionnaires, and clinical rating scales for five years, and researchers will compare people who had deep brain stimulation with those receiving the best available medical treatment. The trial enrolls men and women aged 18 to 70 who are either candidates for deep brain stimulation of the subthalamic nucleus or are on best medical therapy, and it excludes anyone who cannot complete the assessments.
- Who can participate?
- Participants must be between 18 Years and 70 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 10 years.
- 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?
- You will have an initial assessment (T0) and annual follow-up visits for 5 years.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.