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Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Study acronym: BPD_DBS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 26, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v3
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05444907
Lead Sponsor Albino Maia
Collaborators: Centro Hospitalar Lisboa Ocidental, Centro Hospitalar De São João, E.P.E., Unidade Local de Saúde de Coimbra, EPE, Centro Hospitalar de Lisboa Central
Conditions
(from sponsor)
Mania, Parkinson Disease
Related terms Mania, Parkinson Disease
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov