Schizophrenia / Schizoaffective DisorderNCT07818668
tACS for Self-Other Boundary in Schizophrenia
A study testing Transcranial Alternating Current Stimulation (tACS) in people with Schizophrenia / Schizoaffective Disorder, run by Chunyan Zhu at 1 site in China.
Trial summary
This clinical trial investigates whether a non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) can improve the ability to distinguish between "self" and "others" in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia / Schizoaffective Disorder
- What is being tested?
- Transcranial Alternating Current Stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 30 Sep 2027
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia according to DSM-5 criteria
- Presence of hallucinations or delusions
- Age between 18 and 50 years
- Clinically stable on a stable dose of antipsychotic medication for at least 4 weeks prior to enrollment, with no anticipated medication changes during the study period
- Normal or corrected-to-normal vision (≥ 20/40) as assessed by standard visual acuity test
- Able to understand and provide written informed consent
Who cannot join
- History of neurological disorders (e.g., epilepsy, stroke, traumatic brain injury)
- Presence of other major psychiatric disorders (e.g., bipolar disorder, major depressive disorder)
- Previous receipt of non-invasive brain stimulation (e.g., tACS, tDCS, rTMS)
- History of substance dependence or abuse within the past 6 months
- Metal implants in the head or skull (e.g., cochlear implants, deep brain stimulators)
- Pregnancy or breastfeeding
- Presence of skin lesions, wounds, or sensitive skin at electrode placement sites (Fpz, AF7, AF8, F5, F6)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth People's Hospital of Hefei
Hefei, Anhui
Su Xiang Meng, 13637088953, 674807609@qq.com
About this study
Official title: Transcranial Alternating Current Stimulation (tACS) at 10 Hz Targeting Medial Prefrontal Cortex for Improving Self-Other Differentiation in Patients With Schizophrenia: A Randomized, Double-Blind, Sham-Controlled Trial
This clinical trial investigates whether a non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) can improve the ability to distinguish between "self" and "others" in patients with schizophrenia. The intervention targets the medial prefrontal cortex (mPFC), a brain region critical for self-awareness, using 10Hz stimulation at 2mA for 20 minutes daily over five consecutive days.
The study has two main objectives. First, it aims to characterize the underlying mechanisms of self-other boundary dysfunction in schizophrenia by comparing behavioral and brain activity patterns among three participant groups: patients with schizophrenia, individuals with high schizotypal traits, and healthy volunteers. During this mechanism phase, participants perform two computer-based self-other face recognition tasks designed to manipulate prior probability (varying the proportion of self vs. other faces across blocks) and perceptual uncertainty (adjusting the Gaussian blur level of face images), while their brain activity is recorded via EEG. Behavioral performance (response time, accuracy, and sensitivity d') and EEG markers (alpha-band power, N170, and P1 components) are analyzed to quantify deficits in predictive coding.
Read more
Second, the study aims to evaluate the therapeutic efficacy of tACS in a randomized, double-blind, sham-controlled trial. The primary hypothesis is that active tACS, compared to sham stimulation, will significantly improve patients' accuracy in distinguishing self from other faces, accompanied by enhanced alpha-band brain oscillations and reduced scores on the Examination of Anomalous Self-Experience (EASE) scale.
All participants will undergo clinical assessments, complete the face recognition tasks while their brain activity is monitored via EEG, and complete follow-up assessments 48 hours after the last stimulation session. The findings from this study may provide a novel, mechanism-based non-pharmacological intervention for addressing core self-disturbance in schizophrenia, potentially improving patients' social functioning and quality of life.
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Being tested
- Transcranial Alternating Current Stimulation (tACS), Sham Transcranial Alternating Current Stimulation (tACS)
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current Stimulation (tACS)Device
10Hz tACS with 2mA intensity, 20 minutes per day
Sham Transcranial Alternating Current Stimulation (tACS)Device
Sham stimulation with identical electrode placement and procedures as the active tACS group. Current is delivered only during the 30-second ramp-up and ramp-down periods, with no active stimulation for the remainder of the 20-minute session.
| Study group | Role | What they receive |
|---|---|---|
| Active tACS Group | Active comparator | Participants receive 10Hz transcranial alternating current stimulation (tACS) at 2mA intensity, targeting the medial prefrontal cortex (mPFC), for 20 minutes per day over 5 consecutive days. Receives: Device: Transcranial Alternating Current Stimulation (tACS) |
| Sham tACS Group | Sham comparator | Participants receive sham stimulation with identical electrode placement and procedures as the active group, but current is delivered only during the 30-second ramp-up and ramp-down periods, with no active stimulation for the remainder of the 20-minute session. Receives: Device: Sham Transcranial Alternating Current Stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Other Face Recognition Sensitivity (d')
Change from baseline in the sensitivity index (d') measured by the self-other face recognition task at 48 hours after the last tACS session. Participants distinguish between self and other faces under varying prior probability and perceptual uncertainty conditions. The sensitivity index (d') is dimensionless; a higher value indicates better ability to differentiate between self and other faces.
Measured: Baseline (pre-intervention) and 48 hours after the last tACS session
Change in Medial Prefrontal Cortex Alpha-Band Oscillatory Power
Change from baseline in alpha-band (8-13 Hz) oscillatory power measured by electroencephalography (EEG) over the medial prefrontal cortex (mPFC) at 48 hours after the last tACS session. Alpha-band power is assessed during resting-state and self-other face recognition task performance to evaluate the neural effects of the intervention.
Measured: Baseline (pre-intervention) and 48 hours after the last tACS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start17 Mar 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia / Schizoaffective DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunyan Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunyan Zhu, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818668
- Sponsor's protocol ID
- 81250874
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation (tACS) at 10 Hz Targeting Medial Prefrontal Cortex for Improving Self-Other Differentiation in Patients With Schizophrenia: A Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07818668
- Acronym / sponsor ID
- 81250874
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chunyan ZhuUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Sep 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.
This clinical trial investigates whether a non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) can improve the ability to distinguish between "self" and "others" in patients with schizophrenia. The intervention targets the medial prefrontal cortex (mPFC), a brain region critical for self-awareness, using 10Hz stimulation at 2mA for 20 minutes daily over five consecutive days.
The study has two main objectives. First, it aims to characterize the underlying mechanisms of self-other boundary dysfunction in schizophrenia by comparing behavioral and brain activity patterns among three participant groups: patients with schizophrenia, individuals with high schizotypal traits, and healthy volunteers. During this mechanism phase, participants perform two computer-based self-other face recognition tasks designed to manipulate prior probability (varying the proportion of self vs. other faces across blocks) and perceptual uncertainty (adjusting the Gaussian blur level of face images), while their brain activity is recorded via EEG. Behavioral performance (response time, accuracy, and sensitivity d') and EEG markers (alpha-band power, N170, and P1 components) are analyzed to quantify deficits in predictive coding.
Second, the study aims to evaluate the therapeutic efficacy of tACS in a randomized, double-blind, sham-controlled trial. The primary hypothesis is that active tACS, compared to sham stimulation, will significantly improve patients' accuracy in distinguishing self from other faces, accompanied by enhanced alpha-band brain oscillations and reduced scores on the Examination of Anomalous Self-Experience (EASE) scale.
All participants will undergo clinical assessments, complete the face recognition tasks while their brain activity is monitored via EEG, and complete follow-up assessments 48 hours after the last stimulation session. The findings from this study may provide a novel, mechanism-based non-pharmacological intervention for addressing core self-disturbance in schizophrenia, potentially improving patients' social functioning and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS Group | Active comparator | Device: Transcranial Alternating Current Stimulation (tACS)Participants receive 10Hz transcranial alternating current stimulation (tACS) at 2mA intensity, targeting the medial prefrontal cortex (mPFC), for 20 minutes per day over 5 consecutive days. |
| Sham tACS Group | Sham comparator | Device: Sham Transcranial Alternating Current Stimulation (tACS)Participants receive sham stimulation with identical electrode placement and procedures as the active group, but current is delivered only during the 30-second ramp-up and ramp-down periods, with no active stimulation for the remainder of the 20-minute session. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia according to DSM-5 criteria
- Presence of hallucinations or delusions
- Age between 18 and 50 years
- Clinically stable on a stable dose of antipsychotic medication for at least 4 weeks prior to enrollment, with no anticipated medication changes during the study period
- Normal or corrected-to-normal vision (≥ 20/40) as assessed by standard visual acuity test
Key exclusion criteria (7 listed)
- History of neurological disorders (e.g., epilepsy, stroke, traumatic brain injury)
- Presence of other major psychiatric disorders (e.g., bipolar disorder, major depressive disorder)
- Previous receipt of non-invasive brain stimulation (e.g., tACS, tDCS, rTMS)
- History of substance dependence or abuse within the past 6 months
- Metal implants in the head or skull (e.g., cochlear implants, deep brain stimulators)
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 Alternating Current Stimulation (tACS)10Hz tACS with 2mA intensity, 20 minutes per day | Device | Active tACS Group |
| Sham Transcranial Alternating Current Stimulation (tACS)Sham stimulation with identical electrode placement and procedures as the active tACS group. Current is delivered only during the 30-second ramp-up and ramp-down periods, with no active stimulation for the remainder of the 20-minute session. | Device | Sham tACS Group |
Primary outcome
Change in Self-Other Face Recognition Sensitivity (d')
Time frame: Baseline (pre-intervention) and 48 hours after the last tACS session
Change from baseline in the sensitivity index (d') measured by the self-other face recognition task at 48 hours after the last tACS session. Participants distinguish between self and other faces under varying prior probability and perceptual uncertainty conditions. The sensitivity index (d') is dimensionless; a higher value indicates better ability to differentiate between self and other faces.
Change in Medial Prefrontal Cortex Alpha-Band Oscillatory Power
Time frame: Baseline (pre-intervention) and 48 hours after the last tACS session
Change from baseline in alpha-band (8-13 Hz) oscillatory power measured by electroencephalography (EEG) over the medial prefrontal cortex (mPFC) at 48 hours after the last tACS session. Alpha-band power is assessed during resting-state and self-other face recognition task performance to evaluate the neural effects of the 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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia / Schizoaffective Disorder
Not yet recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2
SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Not yet recruiting
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Schizophenia Disorder, Severe Mental Illness
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation (tACS) in people with Schizophrenia / Schizoaffective Disorder, run by Chunyan Zhu at 1 site in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 long chen (18712333621, chen37213@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Other Face Recognition Sensitivity (d') (time frame: Baseline (pre-intervention) and 48 hours after the last tACS session). The study lists 2 primary outcomes in all. 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 17 Sep 2026.