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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Paul Shotbolt, PhD
- 電話番号：+4402078365454
- メール：paul.shotbolt@kcl.ac.uk
研究場所
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England
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London、England、イギリス、WC2R 2LS
- King's College London
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コンタクト：
- Research Governance Office of King's College London
- 電話番号：+4402078365454
- メール：rgo@kcl.ac.uk
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Shanghai、中国
- Ruijin Hospital
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コンタクト：
- Li
- 電話番号：021-64370045
- メール：ldy11483@rjh.com.cn
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Identification of Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Temporal Dynamics of Neuropsychiatric Symptoms
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LFP-in-PD-333102
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。