No Intervention / Exposure for Parkinson's (NCT05444907)
Prevent mania after brain stimulation
- Trial ID
- NCT05444907
- Official Title
- Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment
- Goal
- Prevent mania after brain stimulation
- Status
- RECRUITING
- Sponsor
- Albino Maia
- Study Type
- OBSERVATIONAL
- Enrollment
- 100 participants
- Conditions
- Mania, Parkinson Disease
- Interventions
- No Intervention / Exposure
Summary For Families
The goal is to find clinical and stimulation-related factors that predict mania after deep brain stimulation, so clinicians can pick targets and programming that lower that risk. The team will compare people with Parkinson's who developed a manic or mixed affective state after the device was switched on or its settings were changed to similar DBS-treated patients who did not, looking at stimulation target and parameters, medications, and clinical history; DBS works by sending electrical pulses to specific brain areas to improve motor symptoms, but those pulses can sometimes activate nearby mood circuits and trigger mania, and it may change how much levodopa someone needs. Adults 18 and older who had DBS for Parkinson's are eligible, with one group having a post-activation or post-programming manic episode and a control group without such episodes, and anyone with bipolar disorder or a history of mania before surgery or before age 18 is excluded.
Locations
- Champalimaud Foundation, Lisbon, Portugal
Frequently Asked Questions
- What is this trial testing?
- This trial is studying No Intervention / Exposure. The goal is to find clinical and stimulation-related factors that predict mania after deep brain stimulation, so clinicians can pick targets and programming that lower that risk. The team will compare people with Parkinson's who developed a manic or mixed affective state after the device was switched on or its settings were changed to similar DBS-treated patients who did not, looking at stimulation target and parameters, medications, and clinical history; DBS works by sending electrical pulses to specific brain areas to improve motor symptoms, but those pulses can sometimes activate nearby mood circuits and trigger mania, and it may change how much levodopa someone needs. Adults 18 and older who had DBS for Parkinson's are eligible, with one group having a post-activation or post-programming manic episode and a control group without such episodes, and anyone with bipolar disorder or a history of mania before surgery or before age 18 is excluded.
- 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 4 years and 7 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.
- 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.