Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKing's College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults with Parkinson's disease and co-occurring neuropsychiatric symptoms, including hallucinations, impulse control disorder, or episodic anxiety, who previously underwent bilateral Deep Brain Stimulation implantation with a Medtronic Percept device as part of routine clinical care at King's College Hospital or affiliated services.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Parkinson's Disease Participants With Neuropsychiatric Symptoms and DBS

Trial outcomes

Primary outcomes

1

Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease

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

Secondary outcomes

1

Temporal Dynamics of Neuropsychiatric Symptoms

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 through Day 120
2

Association Between LFP Features and Behavioural Task Performance

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
3

Association Between LFP Features and Clinical Symptom Severity Measures

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).

Time frame
Baseline assessment at Day 0

Other outcomes

Sponsors and contacts

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King's College London

Lead sponsor

Ruijin Hospital

Collaborator

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