NCT05444907Recruiting
Deep Brain Stimulation-Induced Mania in Parkinson's Disease
Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment
Source: ClinicalTrials.gov · Last updated 26 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jun 2022
- Start date
- 25 May 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Albino Maia
- Diseases
- Parkinson disease
- NCT number
- NCT05444907
What you commit to
- Study type: Observational
- Planned participants: 100
- From 25 May 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18
Who the study is looking for
- 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.
Criteria the registry did not label
- DBS-induced mania cohort:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Champalimaud Foundation Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.