Precision HD-tACS for Enhancing Sensory Experience in Schizophrenia (TherACles)
Precision HD-tACS-Based Therapy for the Qualitative and Phenomenological Enhancement of Sensory Experiences in Schizophrenia
To ensure unified sensory perception, the brain must link information from different senses across time and space. This unification of perception often referred to as a perceptual "binding constraint" is a prerequisite for any organized perception. Patients with schizophrenia exhibit deficits in the spatiotemporal binding of sensory information . Electroencephalography (EEG) studies highlight the role of delta-theta oscillatory dynamics (2-8 Hz) in neuronal entrainment processes underlying spatiotemporal binding, which enables the formation of a coherent and organized perceptual representation . These same dynamics are disrupted in schizophrenia .
In tasks assessing perceptual binding, such alterations manifest as widened temporal binding windows, reflecting impaired temporal structuring of visual events. Physiologically, these disruptions may stem from impaired feedback mechanisms within the cortico-cerebello-thalamo-cortical (CCTC) loop. Schizophrenia patients also exhibit functional and structural deficits in the pulvinar and frontal cortex, key nodes of the CCTC loop .
Recent technical advances in transcranial neurostimulation have reinforced its potential as a therapeutic tool. High-definition transcranial alternating current stimulation (HD-tACS) now enables individualized modulation of pre-identified neural networks , including targeted interventions for schizophrenia . Based on a personalized stimulation protocol, this research project proposes precision HD-tACS therapy, tailored for each patient according to their delta-theta peak frequency measured via EEG and the optimal functional stimulation site identified with functional MRI (fMRI). Stimulation will be applied functionally, i.e., while the patient performs a cognitive task.
Structural connectivity alterations have been observed in fronto-thalamic, thalamo-cingulate, and cortico-cerebellar pathways in schizophrenia, potentially underpinning temporal and spatial binding deficits. Assessing the integrity of the CCTC loop with diffusion tensor imaging (DTI) will allow quantification of fiber coherence and white matter density connecting cortical and subcortical regions within this network.To evaluate both baseline perceptual deficits and the potential improvements induced by stimulation, a control group of healthy participants will be included.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Lydie SARTELET
- Номер телефона: +334 37 91 55 31
- Электронная почта: lydie.sartelet@ch-le-vinatier.fr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria for control group and patient:
- Be aged 18 to 65 years inclusive.
- Have read and understood the study information sheet.
- Be affiliated with a social security system or be a beneficiary.
- Have normal or corrected-to-normal vision (glasses or contact lenses).
Exclusion Criteria for control group :
- Any contraindication to tACS, e.g., cardiac pacemaker or other devices that could interfere with the electric field.
- Any contraindication to MRI, e.g., neurological stimulator, pacemaker, cardiac defibrillator, cardiac or vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metallic fragments in the eyes, cochlear implants, severe claustrophobia. (A standardized MRI screening questionnaire will be provided.)
- Pregnancy or breastfeeding. (Pregnancy status will be verified with a test on the day of the exam.)
- Legal incapacity (under guardianship, conservatorship, or judicial/administrative detention) or inability to provide informed consent.
- Major psychiatric disorders (excluding tobacco use disorder).
- Neurological disorders.
- Severe somatic disorders that could interfere with participation.
- Uncorrected visual impairments.
- Recent consumption of substances likely to alter brain activity (alcohol, drugs, etc.).
- Presence of any psychiatric disorder.
- Under legal protection (guardianship or conservatorship).
Exclusion Criteria - Patient Group
A potential patient participant will be excluded if they have:
- Any contraindication to tACS, e.g., cardiac pacemaker or other devices that could interfere with the electric field.
- Any contraindication to MRI, e.g., neurological stimulator, pacemaker, cardiac defibrillator, cardiac or vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metallic fragments in the eyes, cochlear implants, severe claustrophobia. (A standardized MRI screening questionnaire will be provided.)
- Pregnancy or breastfeeding. (Pregnancy status will be verified with a test on the day of the exam.)
- Legal incapacity (under guardianship, conservatorship, or judicial/administrative detention) or inability to provide informed consent.
- Major psychiatric disorders other than schizophrenia (excluding tobacco use disorder).
- Neurological disorders.
- Severe somatic disorders that could interfere with participation.
- Uncorrected visual impairments.
- Recent consumption of substances likely to alter brain activity (alcohol, drugs, etc.).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Control Group Theta active
|
Active HD-tACS
|
|
Фальшивый компаратор: Control Group Sham
|
Sham HD-tACS
|
|
Активный компаратор: Schizophrenic patients Group Theta active
|
Active HD-tACS
|
|
Фальшивый компаратор: Schizophrenic patients Group Sham
|
Sham HD-tACS
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Point of subjective equality(PSE)
Временное ограничение: Day1: pre-intervention From 2 days to 20 days maximum: intervention and post-intervention
|
This outcome measures perceptual bias by estimating the Point of Subjective Equality (PSE), defined as the stimulus intensity at which participants perceive two stimuli as equal with 50% probability.
The PSE is extracted from a fitted psychometric function and compared between PRE and POST phases.
Unit: same as stimulus dimension (e.g., ms, Hz, or intensity level).
No fixed min/max value
|
Day1: pre-intervention From 2 days to 20 days maximum: intervention and post-intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Functional connectivity, assessed via the phase-locking value (PLV).
Временное ограничение: Day1: pre-intervention From 2 days to 20 days maximum: post-intervention
|
Electrophysiological data analysis will focus on signal coherence, measured by the phase-locking value (PLV).
The PLV quantifies over time the phase-locking differences (Δφ) between different topographical points.
When EEG activity is entrained by an external stimulation, signal coherence increases, and Δφ remains consistent across trials.
Conversely, if there is no relationship between the signals recorded at different scalp locations, Δφ will vary randomly across trials.
Δφ values will be compared between the PRE and POST stimulation phases.
Index between 0 and 1
|
Day1: pre-intervention From 2 days to 20 days maximum: post-intervention
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: William VALLET, PhD, Le Vinatier Psychiatrie Universitaire Lyon Métropole
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2025-A02370-49
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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