Investigating Mania Induced by Deep Brain Stimulation in Parkinson's Disease
Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment
This study looks at people with Parkinson's Disease who have had deep brain stimulation surgery to see if certain factors can help explain why some of them experience mania afterwards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacao Champalimaud Academic / other |
| Locations | 1 site (Lisbon) |
| Trial ID | NCT05444907 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Parkinson's Disease who have undergone deep brain stimulation (DBS) surgery and subsequently experienced mania or mixed affective states. The researchers aim to identify specific sociodemographic and clinical predictors, such as stimulation parameters and electrode locations, that may be associated with the occurrence of DBS-induced mania. By analyzing a cohort of patients who experienced these neuropsychiatric side effects compared to a control group, the study seeks to clarify the underlying mechanisms and improve patient outcomes. The findings could enhance understanding of the risks associated with DBS in Parkinson's Disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Parkinson's Disease who have undergone DBS surgery and experienced mania after the procedure.
Not a fit: Patients with a history of bipolar disorder or those who experienced manic episodes prior to DBS surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for preventing mania in Parkinson's patients undergoing DBS.
How similar studies have performed: While there is limited research specifically on DBS-induced mania, studies on neuropsychiatric effects of DBS in other contexts suggest that understanding these side effects is crucial for improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
DBS-induced mania cohort: Inclusion Criteria: * Age≥18-years-old; * Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target; * Manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters. Exclusion Criteria: * Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18 * Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state, before DBS surgery. DBS Control Cohort: A control cohort will also be collected. These patients will also meet the aforementioned inclusion and exclusion criteria with the exception of not having presented a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation.
Where this trial is running
Lisbon
- Champalimaud Foundation — Lisbon, Portugal (Recruiting)
Study contacts
- Principal investigator: Albino J. Oliveira-Maia, MD, MPH, PhD — Champalimaud Foundation
- Study coordinator: Sofia Marques
- Email: sofia.marques@research.fchampalimaud.org
- Phone: +351 210 480 048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.