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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Champalimaud Foundation
RECRUITING
Lisbon
Contact Information
Primary
Sofia Marques
sofia.marques@research.fchampalimaud.org
+351 210 480 048
Time Frame
Start Date: 2021-05-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
DBS-induced Mania Cohort
Patients diagnosed with Parkinson's Disease (PD) who were submitted to deep brain stimulation (DBS) surgery irrespective of its target and who developed a 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.
DBS Control Cohort
Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target and who did not develop DBS-induced mania.
Sponsors
Collaborators: Centro Hospitalar de Lisboa Central, Unidade Local de Saúde de Coimbra, EPE, Centro Hospitalar De São João, E.P.E., Centro Hospitalar Lisboa Ocidental
Leads: Albino Maia

This content was sourced from clinicaltrials.gov

Similar Clinical Trials