- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Paul Shotbolt, PhD
- 전화번호: +4402078365454
- 이메일: paul.shotbolt@kcl.ac.uk
연구 장소
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England
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London, England, 영국, WC2R 2LS
- King's College London
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연락하다:
- Research Governance Office of King's College London
- 전화번호: +4402078365454
- 이메일: rgo@kcl.ac.uk
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Shanghai, 중국
- Ruijin Hospital
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연락하다:
- Li
- 전화번호: 021-64370045
- 이메일: ldy11483@rjh.com.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Temporal Dynamics of Neuropsychiatric Symptoms
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LFP-in-PD-333102
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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