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?
- 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 4 years and 7 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.