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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Lydie SARTELET
- Numero di telefono: +334 37 91 55 31
- Email: lydie.sartelet@ch-le-vinatier.fr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Control Group Theta active
|
Active HD-tACS
|
|
Comparatore fittizio: Control Group Sham
|
Sham HD-tACS
|
|
Comparatore attivo: Schizophrenic patients Group Theta active
|
Active HD-tACS
|
|
Comparatore fittizio: Schizophrenic patients Group Sham
|
Sham HD-tACS
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Point of subjective equality(PSE)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Functional connectivity, assessed via the phase-locking value (PLV).
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: William VALLET, PhD, Le Vinatier Psychiatrie Universitaire Lyon Métropole
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2025-A02370-49
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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