Actively Recruiting

Age: 18Years +
All Genders
NCT05444907

Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Led by Albino Maia · Updated on 2025-02-26

100

Participants Needed

1

Research Sites

240 weeks

Total Duration

On this page

Sponsors

A

Albino Maia

Lead Sponsor

C

Centro Hospitalar Lisboa Ocidental

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of Parkinson's Disease and undergone DBS surgery regardless of target location
  • Manic episode or mixed affective state diagnosed after surgery linked to DBS device activation or parameter changes
Not Eligible

You will not qualify if you...

  • Diagnosis of bipolar disorder, manic episode, or mixed affective state before age 18
  • Diagnosis of bipolar disorder, manic episode, or mixed affective state before DBS surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Champalimaud Foundation

Lisbon, Portugal, 1400-038

Actively Recruiting

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Research Team

S

Sofia Marques

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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