- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07820553
Building a Computational Model of Auditory Hallucinations (CLARITY WP1)
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
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: CLARITY Study Contact
- Número de telefone: +447871777185
- E-mail: clarity@kcl.ac.uk
Estude backup de contato
- Nome: Maria D Paduraru
- Número de telefone: 020 7848 0100
- E-mail: maria-diana.paduraru@kcl.ac.uk
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
Inclusion Criteria:
PWLEP:
- Age 16-65 years.
- A score of at least 3 on the state section of the Auditory Perceptual Trait and State scale (APTS).
- If using an antipsychotic drug, participants must be on a stable dose of any medication during the baseline measures.
- 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.
- Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study.
- 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:
- Age 16-65 years.
- 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.
- Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study.
- 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:
- 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.
- 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.
- Recent history (i.e. in the last 12 months) of epilepsy or seizures.
- Homicidal ideation or intent, as judged by a researcher; suicidal ideation, with some intent to act, or suicidal behaviour, as judged by a researcher.
- History of drug or alcohol dependence (except for caffeine and nicotine and mild/moderate cannabis dependence) in the 3 months before study start.
- Likelihood that the participant will not comply with the requirements of the protocol.
- 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).
- 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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
E/I balance determined using the computational model based on the 40-Hz auditory steady-state response (ASSR) EEG response.
Prazo: Baseline
|
Computational model will be created after study end, using EEG data acquired at the baseline study visit.
|
Baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mismatch Negativity (MMN): E/I balance determined using MMN amplitude and latency measured using EEG.
Prazo: Baseline
|
Baseline
|
|
|
Relationship between E/I balance and auditory perceptual symptom severity, assessed using the Auditory Perceptual Trait and State Scale.
Prazo: Baseline
|
Baseline
|
|
|
EEG Resting-State Activity: Power across frequency bands (delta, theta, alpha, beta, gamma) during resting-state EEG.
Prazo: Baseline
|
Baseline
|
|
|
Auditory Oddball P300: Amplitude of the P300 event-related potential in response to an auditory oddball, measured using EEG.
Prazo: Baseline
|
Baseline
|
|
|
fMRI Resting-State Connectivity
Prazo: Baseline
|
E/I balance determined using functional connectivity between key brain regions (e.g., auditory cortex, prefrontal cortex) assessed by resting-state fMRI.
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Transtornos Mentais, Desordem Mental
- Manifestações Neurocomportamentais
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Esquizofrenia
- Transtornos Psicóticos
- Alucinações
Outros números de identificação do estudo
- 368570
- REC Approval Number:26/LO/0524 (Outro identificador: London - Camden and Kings Cross REC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .