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Deep Brain Stimulation-Induced Mania in Parkinson's Disease

NCT05444907 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-26

No results posted yet for this study

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.

Conditions

  • Mania
  • Parkinson Disease

Interventions

OTHER

No Intervention / Exposure

No intervention / exposure since this is an observational study

Sponsors & Collaborators

  • Centro Hospitalar Lisboa Ocidental

    collaborator OTHER_GOV

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER

  • Unidade Local de Saúde de Coimbra, EPE

    collaborator OTHER

  • Centro Hospitalar de Lisboa Central

    collaborator OTHER

  • Albino Maia

    lead OTHER

Principal Investigators

  • Albino J. Oliveira-Maia, MD, MPH, PhD · Champalimaud Foundation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444907 on ClinicalTrials.gov