SCHIZOPHRENIA 1 (Disorder)TherAClesNCT07632261
Precision HD-tACS for Enhancing Sensory Experience in Schizophrenia
A study testing Transcranial neurostimulation in people with SCHIZOPHRENIA 1 (Disorder) and Sensory Perceptual Characteristics, run by Hôpital le Vinatier.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Sensory Perceptual Characteristics
- What is being tested?
- Transcranial neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
- 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.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read more
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.
- Being tested
- Transcranial neurostimulation, Sham Transcranial neurostimulation
- Keywords
- perceptual binding, sensory perception, transcranial stimulation, tACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial neurostimulationDevice
Active HD-tACS
Sham Transcranial neurostimulationDevice
Sham HD-tACS
| Study group | Role | What they receive |
|---|---|---|
| Control Group Theta active | Active comparator | Not described Receives: Device: Transcranial neurostimulation |
| Control Group Sham | Sham comparator | Not described Receives: Device: Sham Transcranial neurostimulation |
| Schizophrenic patients Group Theta active | Active comparator | Not described Receives: Device: Transcranial neurostimulation |
| Schizophrenic patients Group Sham | Sham comparator | Not described Receives: Device: Sham Transcranial neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point of subjective equality(PSE)
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
Measured: Day1: pre-intervention From 2 days to 20 days maximum: intervention and post-intervention
Secondary outcomes (1)
Functional connectivity, assessed via the phase-locking value (PLV).
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
Measured: Day1: pre-intervention From 2 days to 20 days maximum: post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 patient participants and 40 healthy controls
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William VALLET, PhD, Principal investigator, Le Vinatier Psychiatrie Universitaire Lyon Métropole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632261
- Sponsor's protocol ID
- 2025-A02370-49
- Acronym
- TherACles
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision HD-tACS-Based Therapy for the Qualitative and Phenomenological Enhancement of Sensory Experiences in Schizophrenia
- ClinicalTrials.gov ID
- NCT07632261
- Acronym / sponsor ID
- TherACles / 2025-A02370-49
- Keywords
- perceptual binding, sensory perception, transcranial stimulation, tACS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 40 patient participants and 40 healthy controls
| Arm | Type | Receives |
|---|---|---|
| Control Group Theta active | Active comparator | Device: Transcranial neurostimulation |
| Control Group Sham | Sham comparator | Device: Sham Transcranial neurostimulation |
| Schizophrenic patients Group Theta active | Active comparator | Device: Transcranial neurostimulation |
| Schizophrenic patients Group Sham | Sham comparator | Device: Sham Transcranial neurostimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial neurostimulationActive HD-tACS | Device | Control Group Theta active, Schizophrenic patients Group Theta active |
| Sham Transcranial neurostimulationSham HD-tACS | Device | Control Group Sham, Schizophrenic patients Group Sham |
Primary outcome
Point of subjective equality(PSE)
Time frame: 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
1 secondary outcome
Functional connectivity, assessed via the phase-locking value (PLV).
Time frame: Day1: pre-intervention From 2 days to 20 days maximum: post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William VALLET, PhD principal investigator
Le Vinatier Psychiatrie Universitaire Lyon Métropole
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial neurostimulation in people with SCHIZOPHRENIA 1 (Disorder) and Sensory Perceptual Characteristics, run by Hôpital le Vinatier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydie SARTELET (+334 37 91 55 31, lydie.sartelet@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point of subjective equality(PSE) (time frame: Day1: pre-intervention From 2 days to 20 days maximum: intervention and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.