fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

Официальное название

Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial

Обзор

The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations. Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder. Based on this progress, we can track patients' hallucinatory status using real-time fMRI. We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. We will refer to a double-blind randomized placebo-controlled design. A total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 4 runs of either active or sham neurofeedback. The primary outcome measure will be the mean decrease of AHRS scores relative to baseline, and at 1 month post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.

Вмешательства

• Другое Active neurofeedback procedure
  Patients will perform 5 fMRI sessions. Four consecutive fMRI runs (1/ day) during which they will continuously receive visual feedback computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. A 5th fMRI scan will be performed at 1 month post-treatment.
• Другое Sham neurofeedback procedure
  Patients will perform 5 fMRI sessions. Four consecutive fMRI runs (1/ day) during which they will receive a random feedback and a 5th run at 1 month post-treatment.

Первичные конечные точки

• Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity [Срок оценки: 1 month after treatment]

Вторичные конечные точки (9)

• Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity [Срок оценки: 1 month after treatment]
• Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations [Срок оценки: 1 month after treatment]
• Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations [Срок оценки: 1 month after treatment]
• Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations [Срок оценки: 1 month after treatment]
• Changes in global functioning relative to baseline [Срок оценки: 1 month after treatment]
• Changes in quality of life relative to baseline [Срок оценки: 1 month after treatment]
• Changes in structural MRI markers relative to baseline [Срок оценки: 1 month after treatment]
• Changes in structural MRI markers relative to baseline [Срок оценки: 1 month after treatment]
• Changes in functional MRI markers relative to baseline [Срок оценки: 1 month after treatment]

Критерии участия

Критерии включения

• Schizophrenia (according to the DSM-5 classification)
• Frequent auditory hallucinations (SAPS item #1 ≥ 4)
• Stable medication for at least 30 days
• Absence of chronic neurological disorder (including seizure)
• Able to provide free written consent to participate in the research

Критерии исключения

• Pregnancy
• Contraindication to MRI scan
• Claustrophobia
• No social insurance

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hop Fontan Chu — Lille

Идентификаторы

NCT: NCT04798131 · 2020_08 · 2020-A00631-38 · ANR-16-CE37-0015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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