Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Launched by ALBINO MAIA · Jul 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a specific side effect known as mania that can occur in some patients with Parkinson's Disease (PD) who undergo a treatment called deep brain stimulation (DBS). DBS is used to help improve symptoms of PD, but in some cases, it can lead to mood changes, including episodes of mania. The researchers want to understand what factors, such as the patient's age, health status, or the way the DBS device is programmed, might increase the risk of developing mania after surgery. To do this, they will analyze data and brain images from patients who have experienced these mood changes after getting DBS.

To be eligible for this study, participants need to be at least 18 years old and have a diagnosis of Parkinson's Disease. They must have had DBS surgery and experienced a manic episode or mixed mood state after the device was turned on or adjusted. Patients who have a history of bipolar disorder or mood episodes before turning 18 or before their DBS surgery will not be included. Participants can expect to provide information about their health and undergo brain imaging as part of the study. This research aims to improve understanding of the risks associated with DBS, so that doctors can better help patients with Parkinson's Disease.

Gender

ALL

Eligibility criteria

• DBS-induced mania cohort:
• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• DBS Control Cohort:
• • A control cohort will also be collected. These patients will also meet the aforementioned inclusion and exclusion criteria with the exception of not having presented a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation.