Parkinson's disease.
Timothy R Mhyre, James T Boyd, Robert W Hamill...
https://pubmed.ncbi.nlm.nih.gov/23225012Actively Recruiting
Age: 18Years +
All Genders
ID05444907
Understanding Deep Brain Stimulation-induced Mania in Parkinson's Disease to Find Predictors for Better Treatment
Led by Albino Maia · Updated on 2025-02-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Albino Maia
Lead Sponsor
C
Centro Hospitalar Lisboa Ocidental
Collaborating Sponsor
AI-Summary
What this Trial Is About
Parkinson's Disease (PD) is a common neurodegenerative disorder that causes severe motor and non-motor symptoms. While medication can help manage symptoms, some patients do not respond well or experience side effects. Deep brain stimulation (DBS) is used for these cases to improve symptoms and quality of life, but it can sometimes cause serious neuropsychiatric side effects such as DBS-induced mania, which affects mood and can reduce treatment benefits. The exact causes of this condition are not well understood. This observational study compares two groups of PD patients who have had DBS surgery: those who developed mania or a mixed mood episode after DBS and those who did not. The researchers will examine clinical records and neuroimaging data collected during routine care to identify if specific stimulation settings, electrode locations, or patient characteristics are linked to DBS-induced mania. They will use advanced brain imaging analyses to map the brain areas and networks affected by DBS that might be involved in this side effect. Participants' medical history, stimulation parameters, and brain scans will be reviewed retrospectively. The main outcome is the location of brain tissue activation associated with mania after DBS. Researchers will also study clinical and sociodemographic factors and brain connectivity patterns to understand predictors of this condition. Data will be analyzed up to 24 months after the first manic symptoms. The study aims to improve knowledge about DBS-induced mania to help optimize treatments for PD patients receiving DBS.
CONDITIONS
Brief Title
Deep Brain Stimulation-Induced Mania in Parkinson's Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with Parkinson's Disease
- Have undergone deep brain stimulation surgery regardless of target
- For the mania cohort: developed a manic episode or mixed affective state after DBS surgery linked to stimulation changes
You will not qualify if you...
- Diagnosed with bipolar disorder, manic episode, or mixed affective state before age 18
- Diagnosed with bipolar disorder, manic episode, or mixed affective state before DBS surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 24 months
Participants who underwent deep brain stimulation surgery are assessed to identify the development of DBS-induced mania and to determine associated clinical and sociodemographic factors.
Visits as needed for clinical assessments and documentation of manic symptoms
Long-term Monitoring
Duration - Up to 24 months
Participants continue to be monitored for changes in brain connectivity and symptom development related to DBS stimulation parameters over time.
Periodic visits depending on symptom emergence and clinical follow-up
Trial Site Locations
Total: 1 location
1
Champalimaud Foundation
Lisbon, Portugal, 1400-038
Actively Recruiting
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Research Team
S
Sofia Marques
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Clinical practice. Diagnosis and initial management of Parkinson's disease.
John G Nutt, G Frederick Wooten
https://pubmed.ncbi.nlm.nih.gov/16148287Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease.
A L Benabid, P Pollak, A Louveau...
https://pubmed.ncbi.nlm.nih.gov/3329873Bilateral chronic electrostimulation of ventroposterolateral pallidum: a new therapeutic approach for alleviating all parkinsonian symptoms.
J Siegfried, B Lippitz
https://pubmed.ncbi.nlm.nih.gov/7885558[Effects of the stimulation of the subthalamic nucleus in Parkinson disease].
P Pollak, A L Benabid, C Gross...
https://pubmed.ncbi.nlm.nih.gov/8235208Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease.
Deep-Brain Stimulation for Parkinson's Disease Study Group, J A Obeso, C W Olanow...
https://pubmed.ncbi.nlm.nih.gov/11575287The psychiatric and neuropsychiatric symptoms after subthalamic stimulation for Parkinson's disease.
Philip E Mosley, Rodney Marsh
https://pubmed.ncbi.nlm.nih.gov/25716484Mood Effects After Deep Brain Stimulation for Parkinson's Disease: An Update.
Ettore A Accolla, Claudio Pollo
https://pubmed.ncbi.nlm.nih.gov/31258509The site of stimulation moderates neuropsychiatric symptoms after subthalamic deep brain stimulation for Parkinson's disease.
Philip E Mosley, David Smith, Terry Coyne...
https://pubmed.ncbi.nlm.nih.gov/29876284Network localization of neurological symptoms from focal brain lesions.
Aaron D Boes, Sashank Prasad, Hesheng Liu...
https://pubmed.ncbi.nlm.nih.gov/26264514