Investigating Mania Induced by Deep Brain Stimulation in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Tributyrin for PSP: a virtual, early-phase study

  This study tests whether tributyrin is safe and tolerable in people with Progressive Supranuclear Palsy who are 45 or older, using virtual visits.

  Recruiting Phase 1/2 University of Michigan · Ann Arbor, Michigan · NCT07863180

• A look at why Lewy body conditions cause visual hallucinations

  This study tests brain‑imaging in people with Lewy body diseases who do or don’t experience visual hallucinations, and in healthy volunteers, to see how brain networks might create these images.

  Recruiting NYU Langone Health · New York, New York · NCT07849413

• How physical activity might help people with Parkinson’s disease who have DBS-STN implants

  This study tests whether adding regular physical activity can help people with Parkinson’s who have DBS-STN stimulation by trying a structured physiotherapy approach alongside standard care.

  Recruiting Medical University of Warsaw · Warsaw · NCT07838636

• Can hippotherapy improve mobility, gait, balance, and quality of life in people with Parkinson's disease?

  This pilot trial tests whether adding horse-assisted therapy to standard rehab helps mobility, gait, balance, and perceived health in adults with Parkinson's disease.

  Recruiting Klinik Valens · Valens, Canton of St. Gallen · NCT07802509

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.