NCT07633379

Brief Summary

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 Health

67
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Jun 2026

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Feb 2028

First Submitted

Initial submission to the registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 28, 2026

Last Update Submit

June 2, 2026

Conditions

Outcome Measures

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.

    Baseline through Day 120

Secondary Outcomes (3)

  • Temporal Dynamics of Neuropsychiatric Symptoms

    Baseline through Day 120

  • Association Between LFP Features and Behavioural Task Performance

    Baseline assessment at Day 0

  • Association Between LFP Features and Clinical Symptom Severity Measures

    Baseline assessment at Day 0

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin Hospital

Shanghai, China

Location

King's College London

London, England, WC2R 2LS, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Paul Shotbolt, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in publications may be shared in anonymised form with qualified researchers upon reasonable request and subject to applicable ethical and institutional approvals. Data sharing will comply with participant consent, data protection regulations, and institutional policies.

Locations