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Not yet recruiting NCT07633379

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

Observational PARKINSON DISEASE (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intracranial Local Field Potential (LFP) Correlates of Neuropsychiatric Symptoms in Parkinson's Disease

Overview

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.

Primary outcome measures

  • Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease [Time frame: Baseline through Day 120]
Secondary outcome measures (3)
  • Temporal Dynamics of Neuropsychiatric Symptoms [Time frame: Baseline through Day 120]
  • Association Between LFP Features and Behavioural Task Performance [Time frame: Baseline assessment at Day 0]
  • Association Between LFP Features and Clinical Symptom Severity Measures [Time frame: Baseline assessment at Day 0]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Ruijin Hospital — Shanghai
United Kingdom · 1 center
  • King's College London — London

Identifiers

NCT: NCT07633379 · LFP-in-PD-333102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗