Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlbino Maia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18

Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state, before DBS surgery.

Trial population

The study cohort will be collected retrospectively from DBS surgery databases from different Movement Disorders and Functional Surgery Groups and further analyzed at the Champalimaud Neuropsychiatry Unit. Data collection will be conducted by each center independently under the approval of their respective Ethics Committees. The data that will be analyzed in this project, including neuroimages, has been collected according to the usual clinical practice of the Movement Disorders and Functional Surgery Groups.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • No Intervention / Exposure

    Other intervention

    No intervention / exposure since this is an observational study

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: DBS-induced Mania Cohort1 intervention
Group B: DBS Control Cohort1 intervention

Trial outcomes

Primary outcomes

1

Topographic localization of volume of tissue activation (VTA) in DBS-induced mania

Differences in voxel-wise topographic localization of VTAs between DBS-induced mania in Parkinson's Disease (PD) and DBS PD controls. VTAs will be obtained using DBS electrodes locations and stimulation parameters.

Time frame
From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months

Secondary outcomes

1

Sociodemographic and/or clinical predictors of DBS-induced mania

Level of prediction of different models for DBS-induced mania in PD, when compared to DBS PD controls. Such models will explore different sociodemographic and/or clinical variables.

Time frame
From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
2

Connectivity profile of volume of tissue activation (VTA) in DBS-induced mania

Differences in voxel-wise connectivity profile of VTAs between DBS-induced mania in PD and DBS PD controls.

Time frame
From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albino Maia

Lead sponsor

Fundacao Champalimaud

Sponsor institution

Centro Hospitalar Lisboa Ocidental

Collaborator

Centro Hospitalar De São João, E.P.E.

Collaborator

Unidade Local de Saúde de Coimbra, EPE

Collaborator

Centro Hospitalar de Lisboa Central

Collaborator