- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Paul Shotbolt, PhD
- Telefonnummer: +4402078365454
- E-post: paul.shotbolt@kcl.ac.uk
Studiesteder
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Shanghai, Kina
- Ruijin Hospital
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Ta kontakt med:
- Li
- Telefonnummer: 021-64370045
- E-post: ldy11483@rjh.com.cn
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England
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London, England, Storbritannia, WC2R 2LS
- King's College London
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Ta kontakt med:
- Research Governance Office of King's College London
- Telefonnummer: +4402078365454
- E-post: rgo@kcl.ac.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Temporal Dynamics of Neuropsychiatric Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LFP-in-PD-333102
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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