Prescriptive Infusion Algorithm (PIA)
NCT07215403
Basal Ganglia Diseases, Brain Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT Number: NCT07633379
This prospective observational cohort study aims to investigate whether intracranial Local Field Potentials (LFPs) recorded from implanted Deep Brain Stimulation (DBS) devices are associated with neuropsychiatric symptoms in people with Parkinson's disease (PD). The study will focus on paroxysmal anxiety, impulse control disorders, and hallucinations.
Twenty participants with Parkinson's disease and an implanted Medtronic Percept DBS device will be recruited. Participants will complete behavioural and clinical assessments and will use the event-marking functionality of the DBS device to record symptom episodes over a monitoring period of approximately 120 days. Brain activity will be passively recorded during this period.
The study will evaluate relationships between LFP signals, symptom occurrence, behavioural task performance, and clinical symptom severity measures. Machine learning approaches will be used to identify electrophysiological patterns associated with neuropsychiatric symptom states at an individual level.
The findings may improve understanding of the neural mechanisms underlying neuropsychiatric symptoms in Parkinson's disease and support the future development of personalised adaptive neuromodulation approaches.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Ruijin Hospital, Shanghai, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline through Day 120
Association between intracranial Local Field Potential (LFP) recordings from the Medtronic Percept Deep Brain Stimulation device and participant-reported neuropsychiatric symptom events, including hallucinations, impulse control symptoms, and episodic anxiety. Machine learning approaches will be used to identify electrophysiological patterns associated with symptom states.
Time frame: Baseline through Day 120
Characterisation of the frequency, timing, and temporal patterns of participant-reported neuropsychiatric symptom events recorded using the Medtronic Percept device event-marking function.
Time frame: Baseline assessment at Day 0
Association between Local Field Potential (LFP) features and performance on reward-processing behavioural tasks, including the Monetary Incentive Delay task and Apple Gathering Task.
Time frame: Baseline assessment at Day 0
Association between Local Field Potential (LFP) features and validated clinical symptom severity scales, including the Neuropsychiatric Inventory (NPI), Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS), and Parkinson Anxiety Scale (PAS).
Contact information is provided by the study sponsor or research team.
King's College London
Other
Intracranial Local Field Potential (LFP) Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
Acronym: LFP-in-PD
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