- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633379
Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease (LFP-in-PD)
Intracranial Local Field Potential (LFP) Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paul Shotbolt, PhD
- Phone Number: +4402078365454
- Email: paul.shotbolt@kcl.ac.uk
Study Locations
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Shanghai, China
- Ruijin Hospital
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Contact:
- Li
- Phone Number: 021-64370045
- Email: ldy11483@rjh.com.cn
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England
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London, England, United Kingdom, WC2R 2LS
- King's College London
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Contact:
- Research Governance Office of King's College London
- Phone Number: +4402078365454
- Email: rgo@kcl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- A diagnosis of Parkinson's Disease
- A diagnosis of hallucinations, impulse control disorder, or panic disorder (episodic anxiety)
- Previous bilateral DBS implantation with a Medtronic Percept device as part of clinical care
Exclusion Criteria:
- Non-English speakers
- <18 years old or >75 years old
- A history of concurrent conditions that could significantly confound the study results, such as other significant neurological condition (e.g., brain injury/infection, substance abuse) or concurrent severe psychiatric condition (e.g., schizophrenia)
- Moderate/severe Intellectual Disability or inability to understand study procedures
- Lack of capacity to consent to the study
- Currently involvement in other studies
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Parkinson's Disease Participants With Neuropsychiatric Symptoms and DBS
Participants with Parkinson's disease and co-occurring neuropsychiatric symptoms, including hallucinations, impulse control disorder, or episodic anxiety, who have previously undergone bilateral Deep Brain Stimulation implantation with a Medtronic Percept device as part of clinical care.
Participants will undergo clinical and behavioural assessments and longitudinal passive recording of intracranial Local Field Potentials (LFPs) over approximately 120 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
Time Frame: Baseline through Day 120
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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.
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Baseline through Day 120
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Temporal Dynamics of Neuropsychiatric Symptoms
Time Frame: Baseline through Day 120
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Characterisation of the frequency, timing, and temporal patterns of participant-reported neuropsychiatric symptom events recorded using the Medtronic Percept device event-marking function.
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Baseline through Day 120
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Association Between LFP Features and Behavioural Task Performance
Time Frame: Baseline assessment at Day 0
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Association between Local Field Potential (LFP) features and performance on reward-processing behavioural tasks, including the Monetary Incentive Delay task and Apple Gathering Task.
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Baseline assessment at Day 0
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Association Between LFP Features and Clinical Symptom Severity Measures
Time Frame: Baseline assessment at Day 0
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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).
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Baseline assessment at Day 0
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LFP-in-PD-333102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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