RecruitingNCT05444907

Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment


Sponsor

Albino Maia

Enrollment

100 participants

Start Date

May 25, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Nevertheless, this approach is, in some cases, associated with incapacitating neuropsychiatric side-effects, including mood disturbances, such as DBS-induced mania. While this condition has important functional short- and long-term consequences for quality of life and prognosis, its pathophysiology is still poorly understood. In this project the investigators propose to conduct a retrospective and naturalistic study in PD patients in whom DBS stimulation resulted in mania or mixed state episode, to clarify if specific sociodemographic and clinical predictors, namely stimulation parameters and target locations, might be associated to the occurrence of this neuropsychiatric adverse event. Additionally, the investigators aim to clarify if the occurrence of DBS-induced mania results from the impact of specific stimulation parameters and/or target locations in functional connectivity networks. To explore this question, the investigators will use different neuroimaging analysis methods termed lesion topography analysis and lesion network mapping, in order to compute maps of the stimulated regions topography and the functional networks that are associated with DBS-mania, respectively. The data that will be analyzed in this project, including neuroimages, will be obtained retrospectively, by different Movement Disorders and Functional Surgery Groups in the context of Deep Brain Stimulation, and that has been collected according to their usual clinical practice.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating manic episodes (periods of abnormally elevated mood, impulsivity, or energy) that appear in people with Parkinson's disease after receiving deep brain stimulation (DBS) therapy. Researchers want to understand why this happens and how to manage it. **You may be eligible if...** - You are 18 years or older - You have Parkinson's disease and have had DBS surgery - You experienced a manic or mixed mood episode after DBS was turned on or its settings were changed - OR you are a Parkinson's DBS patient who has NOT had a manic episode (for the control group) **You may NOT be eligible if...** - You were diagnosed with bipolar disorder or had a manic episode before age 18 - You had a manic or mixed mood episode before your DBS surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Intervention / Exposure

No intervention / exposure since this is an observational study


Locations(1)

Champalimaud Foundation

Lisbon, Portugal

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NCT05444907


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