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Building a Computational Model of Auditory Hallucinations (CLARITY WP1)

2026年9月14日 更新者:King's College London

Building a Computational Model of the Role of Excitation/Inhibition (E/I) Balance in Auditory Hallucinations Using Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI): a Case-control Study

Some people hear voices or sounds that other people cannot hear; these are called auditory hallucinations. The study aims to understand what is happening in the brain when this occurs and will use brain scans to learn more. Greater understanding should help develop better treatments in the future.

調査の概要

詳細な説明

Psychotic disorders, including schizophrenia and bipolar disorder with psychotic features, are severe mental health conditions that significantly diminish quality of life and place a substantial economic burden on society. In England, the total societal cost of schizophrenia is estimated at £11.8 billion per year, with the public sector bearing approximately £7.2 billion of this cost. People with lived experience of psychosis (PWLEP) may experience a range of symptoms, including positive symptoms such as hallucinations and delusions, negative symptoms such as affective flattening, and cognitive impairments, including difficulties with attention, memory and executive function.

Auditory hallucinations, a common and disruptive symptom of psychotic disorders, are typically experienced as hearing voices and occur in approximately 75% of PWLEP. These voices are often intrusive and may be critical, threatening, or commanding, and can be associated with an increased risk of suicide. Whilst antipsychotic treatments, which primarily act through dopamine receptor antagonism, can be effective, they are often associated with significant side effects, and the response to antipsychotic treatment is insufficient in around 40% of patients. There is therefore an urgent need to better understand the mechanisms underlying auditory hallucinations to identify more effective treatment targets and develop novel therapies that act through mechanisms other than dopamine receptor antagonism.

A key avenue for understanding auditory hallucinations is examining disruptions in excitatory-inhibitory (E/I) balance, a fundamental mechanism in neural processing. Post-mortem and in vivo electrophysiological studies implicate dysregulated cortical microcircuits in psychosis, where excitatory pyramidal cells (signalling using glutamate) and inhibitory interneurons (signalling using gamma-aminobutyric acid or 'GABA') regulate neural activity. Interactions between these cells generate synchronised neural oscillations across different frequency bands, from low (delta, theta, alpha) to high (beta, gamma) frequencies. These oscillations, which are crucial for coordinating neural activity and supporting cognitive and perceptual function, can also serve as a measure of E/I balance and be assessed in humans using electroencephalography (EEG).

Previous studies have shown that resting-state cortical theta and gamma oscillations are increased, whilst beta oscillations and evoked gamma are reduced in people with psychosis, indicating altered E/I balance in the cortex. Dynamic causal modelling (DCM) is a validated computational technique for inferring E/I imbalance in both rodent models and humans, allowing a more precise estimate of E/I balance in the human brain to be obtained. Applying DCM to EEG and functional magnetic resonance imaging (fMRI) paradigms-including resting-state recordings, mismatch negativity (MMN), and the 40-Hz auditory steady-state response (ASSR)-has previously shown that pyramidal neuron disinhibition in the auditory cortex (primary auditory cortex and related regions) was associated with auditory perceptual symptoms, serving as a measure of hallucinations.

These findings have been demonstrated in those with chronic psychosis. The investigators now propose to measure E/I early in the presentation of a psychotic disorder to show whether this pathophysiology is related to symptoms demonstrated close to the onset of illness.

The aim of this study is to create a computational model of auditory hallucinations using cortical E/I balance in individuals with a psychotic disorder.

Primary Objective:

The principal research objective is to understand differences in brain signalling, specifically in E/I balance in those with auditory hallucinations using a computational model based on EEG measures such as ASSR relative to healthy volunteers without auditory hallucinations, and whether such measures predict changes in auditory hallucination over time.

Secondary Objectives:

The secondary research objectives include testing if levels of brain and blood substances and genetics are related to brain E/I balance in those with auditory hallucinations and healthy controls.

研究の種類

観察的

入学 (推定)

146

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:CLARITY Study Contact
  • 電話番号:+447871777185
  • メール:clarity@kcl.ac.uk

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

PWLEP: people with auditory perceptual alterations able to get to the study site in London.

Controls: people without psychosis or auditory perceptual alterations able to get to the study site in London.

説明

Inclusion Criteria:

PWLEP:

  1. Age 16-65 years.
  2. A score of at least 3 on the state section of the Auditory Perceptual Trait and State scale (APTS).
  3. If using an antipsychotic drug, participants must be on a stable dose of any medication during the baseline measures.
  4. Sufficient understanding of the nature of the study and any hazards of participating in it, or suitable consultee who can understand this and provide an opinion of what the participant's wishes would be if the participant does not have capacity, if appropriate to do so.
  5. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study.
  6. Capacity to give written consent to participate after reading the information and consent form and after having the opportunity to discuss the study with the investigators or their delegates, or suitable consultee who can understand this and provide an opinion of what the participant's wishes would be if the participant does not have capacity, if appropriate to do so.

Healthy controls:

  1. Age 16-65 years.
  2. Sufficient understanding of the nature of the study and any hazards of participating in it, or suitable consultee who can understand this and provide an opinion of what the participant's wishes would be if the participant does not have capacity, if appropriate to do so.
  3. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study.
  4. Capacity to give written consent to participate after reading the information and consent form and after having the opportunity to discuss the study with the investigators or their delegates, or suitable consultee who can understand this and provide an opinion of what the participant's wishes would be if the participant does not have capacity, if appropriate to do so.

Exclusion Criteria:

PWLEP:

  1. Clinically relevant abnormal history, or laboratory values at the pre-study screening assessment or participation in other research studies that could interfere with the objectives of the study or the safety of the participant, as deemed significant for a study researcher.
  2. Impaired endocrine, cardiac, pulmonary, thyroid, haematological, hepatic, respiratory, neurological, immunological or renal function, or other major disease (e.g. cancer) deemed clinically significant at the time of the study.
  3. Recent history (i.e. in the last 12 months) of epilepsy or seizures.
  4. Homicidal ideation or intent, as judged by a researcher; suicidal ideation, with some intent to act, or suicidal behaviour, as judged by a researcher.
  5. History of drug or alcohol dependence (except for caffeine and nicotine and mild/moderate cannabis dependence) in the 3 months before study start.
  6. Likelihood that the participant will not comply with the requirements of the protocol.
  7. Contraindication to MRI, EEG or other study procedures (for example history of metal implants or metal pieces entering the body that cannot be removed safely, severe claustrophobia, allergy or skin sensitivity to EEG electrode gel).
  8. Any other condition or disability that would make participation in the study procedures not possible (for example severe vision or hearing impairment).

Healthy controls:

As above, and also:

1. No relevant family history of schizophrenia and psychosis (as judged relevant by a study researcher).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
People with lived experience of psychosis (PWLEP)
Age 16-65 years with experience of auditory perceptual alterations as measured by validated scale and able to consent to the study. On stable dose of antipsychotic medication if using. No recent history of epilepsy or seizure within last 12 months.
Control
Age 16-65 years with no relevant family history of schizophrenia and psychosis (as judged relevant by a study researcher) and able to consent to study. No recent history of epilepsy or seizure within last 12 months.

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
E/I balance determined using the computational model based on the 40-Hz auditory steady-state response (ASSR) EEG response.
時間枠:Baseline
Computational model will be created after study end, using EEG data acquired at the baseline study visit.
Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Mismatch Negativity (MMN): E/I balance determined using MMN amplitude and latency measured using EEG.
時間枠:Baseline
Baseline
Relationship between E/I balance and auditory perceptual symptom severity, assessed using the Auditory Perceptual Trait and State Scale.
時間枠:Baseline
Baseline
EEG Resting-State Activity: Power across frequency bands (delta, theta, alpha, beta, gamma) during resting-state EEG.
時間枠:Baseline
Baseline
Auditory Oddball P300: Amplitude of the P300 event-related potential in response to an auditory oddball, measured using EEG.
時間枠:Baseline
Baseline
fMRI Resting-State Connectivity
時間枠:Baseline
E/I balance determined using functional connectivity between key brain regions (e.g., auditory cortex, prefrontal cortex) assessed by resting-state fMRI.
Baseline

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2030年8月1日

研究の完了 (推定)

2030年8月1日

試験登録日

最初に提出

2026年9月8日

QC基準を満たした最初の提出物

2026年9月14日

最初の投稿 (実際)

2026年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

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?

はい

IPD プランの説明

Collected anonymised data may be shared with other researchers within and outside the UK as per open science agreements from the funder Wellcome.

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