- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Paul Shotbolt, PhD
- Numéro de téléphone: +4402078365454
- E-mail: paul.shotbolt@kcl.ac.uk
Lieux d'étude
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Shanghai, Chine
- Ruijin Hospital
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Contact:
- Li
- Numéro de téléphone: 021-64370045
- E-mail: ldy11483@rjh.com.cn
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England
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London, England, Royaume-Uni, WC2R 2LS
- King's College London
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Contact:
- Research Governance Office of King's College London
- Numéro de téléphone: +4402078365454
- E-mail: rgo@kcl.ac.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Temporal Dynamics of Neuropsychiatric Symptoms
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LFP-in-PD-333102
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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