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Precision HD-tACS for Enhancing Sensory Experience in Schizophrenia (TherACles)

5. juni 2026 opdateret af: Hôpital le Vinatier

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Group Theta active
Enhed: Transcranial neurostimulation
Active HD-tACS
Sham-komparator: Control Group Sham
Enhed: Sham Transcranial neurostimulation
Sham HD-tACS
Aktiv komparator: Schizophrenic patients Group Theta active
Enhed: Transcranial neurostimulation
Active HD-tACS
Sham-komparator: Schizophrenic patients Group Sham
Enhed: Sham Transcranial neurostimulation
Sham HD-tACS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Point of subjective equality(PSE)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional connectivity, assessed via the phase-locking value (PLV).
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hôpital le Vinatier

Efterforskere

  • Ledende efterforsker: William VALLET, PhD, Le Vinatier Psychiatrie Universitaire Lyon Métropole

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. juni 2026

Studieafslutning (Anslået)

1. maj 2030

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025-A02370-49

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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