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Deep Brain Stimulation-Induced Mania in Parkinson's Disease

Recruitingn/aAges 18 Years - anyAllAlbino Maia
NCT05444907 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 locat

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📋 Eligibility rules (as published)
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.
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What it tests

  • No Intervention / Exposure
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Where

1 site
Champalimaud Foundation
Lisbon, Portugal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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