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

Plain-Language Summary

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.

View on ClinicalTrials.gov