θTACS for Schizophrenia (SCZ) (θ-sch-dlPFC)

November 10, 2026 updated by: WANG KAI, Anhui Medical University

Efficacy and Safety of θ-transcranial Alternating Current Stimulation for Schizophrenia: A Randomized, Double-Blind, Sham-Controlled Trial

This is a double-blind, sham-controlled randomized study to test whether theta transcranial alternating current stimulation (theta tACS) at 4.5 Hz or 6 Hz, added to standard clinical care, improves symptoms of schizophrenia and is safe and well tolerated. Approximately 150 adults aged 18 to 60 years with schizophrenia will be randomly assigned equally to one of three groups: active 4.5 Hz tACS, active 6 Hz tACS, or sham tACS. Both participants and outcome assessors will be masked to group assignment.

All participants will continue their usual clinical treatment. They will receive one 40-minute tACS session per day over 10 working days (10 sessions total). Symptom assessments will take place at baseline, immediately after the stimulation period, Day 30, and Day 56. Magnetic resonance imaging (MRI) scans will be collected at baseline and post-stimulation. Adverse events will be monitored throughout the study.

The primary goal is to compare whether active theta tACS leads to a greater reduction in overall schizophrenia symptoms from baseline to Day 15 relative to sham tACS. Secondary assessments include symptom changes at other follow-up time points, changes in specific symptom domains, treatment completion rate, safety, and brain imaging changes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized, double-blind, parallel-group, sham-controlled trial aims to evaluate the efficacy, safety and tolerability of two theta-band tACS protocols (4.5 Hz and 6 Hz) as an add-on intervention for adults with schizophrenia. One hundred and fifty eligible participants will be allocated in a 1:1:1 ratio to 4.5 Hz active tACS, 6 Hz active tACS, or sham tACS. All participants maintain stable standard clinical care during the trial. The stimulation schedule consists of 40-minute daily sessions on 10 consecutive working days. Clinical symptom ratings are scheduled at baseline, post-intervention, Day 30 and Day 56. Structural and functional MRI data are acquired at baseline and post-intervention to explore brain correlates of treatment response. Adverse events are actively monitored at all study visits. The primary outcome is the change in total schizophrenia symptom severity from baseline to Day 15, comparing active stimulation arms versus sham. Secondary outcomes include longitudinal symptom trajectories, domain-specific symptom changes, intervention adherence, safety outcomes, and MRI-derived brain measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gongjun Ji, professor

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • the Afffliated Psychological Hospital of Anhui Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 60 years.
  2. Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  3. Positive and Negative Syndrome Scale (PANSS) total score of at least 60 at screening.
  4. Initiation, dose adjustment, or switching of antipsychotic medication within the preceding 72 hours.
  5. The participant or legally authorized representative is able to understand the study procedures and voluntarily provide written informed consent, as applicable.
  6. Ability to cooperate with MRI scanning, TI treatment, clinical assessments, and follow-up visits during the study.

Exclusion Criteria

  1. History of a suicide attempt, or a score of 3 or higher on item 3 (suicidal ideation) of the 17-item Hamilton Depression Rating Scale at screening.
  2. A current DSM-5 diagnosis of another major psychiatric disorder, such as bipolar disorder, major depressive disorder with psychotic features, schizoaffective disorder, or substance/medication-induced psychotic disorder.
  3. A major neurological disorder, such as organic brain damage or severe traumatic brain injury.
  4. A contraindication to TI or MRI, including an implanted electronic device; MRI-incompatible intracranial or other metallic implants; wounds or active infection of the scalp at electrode contact sites; severe allergy to electrodes or conductive materials; severe claustrophobia; inability to lie supine; or another condition judged by the investigator to make TI or MRI unsuitable.
  5. Pregnancy or breastfeeding.
  6. Receipt of TI, another form of transcranial electrical stimulation, or electroconvulsive therapy within the preceding 6 months.
  7. Alcohol or another psychoactive substance use disorder within the preceding 6 months, or urine/blood toxicology at screening indicating recent use of illicit psychoactive substances.
  8. A history of seizures, a clear familial risk of epilepsy, or use of medication that substantially lowers the seizure threshold and cannot be adjusted.
  9. Severe or unstable physical illness, including uncontrolled cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, serious systemic infection, malignancy, or severe endocrine/metabolic abnormalities, that may increase study risk or interfere with study completion in the investigator's judgment.
  10. Severe aggression or impulsivity, agitation, delirium, impaired consciousness, or another acute condition that prevents safe cooperation with TI, MRI, or clinical assessments.
  11. Significant cognitive impairment, intellectual disability, language or hearing impairment, or another condition that prevents understanding of study requirements, completion of assessments, or provision of reliable information.
  12. Participation in another interventional clinical study within 3 months before screening, or current participation in another study that may affect evaluation of efficacy or safety in this study.
  13. Anticipated poor adherence, difficulty completing follow-up, or any other condition that, in the investigator's judgment, would compromise participant safety or rights, interfere with study completion, or affect interpretation of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active 4.5Hz θ tACS Stimulation

participants will receive active 4.5Hz tACS once daily for 10 work days. The central target electrode was placed over F3, with four surrounding return electrodes positioned at FP1, Fz, C3, and F7. Sinusoidal theta-band alternating current was delivered between the central target electrode and the four return electrodes; polarity reverses continuously during stimulation, so no fixed anode or cathode is present.Sinusoidal 4.5Hz theta-band tACS was delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasted 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period.
Device: Active 4.5Hz θ tACS Stimulation

The montage uses one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Sinusoidal theta-band tACS at 4.5 Hz is delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasts 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. Current polarity reverses continuously during stimulation, so no fixed anode or cathode is defined. Participants continue stable standard clinical care throughout the trial.
Experimental: Active 6Hz θ tACS Stimulation

participants will receive active 6Hz tACS once daily for 10 work days. The central target electrode was placed over F3, with four surrounding return electrodes positioned at FP1, Fz, C3, and F7. Sinusoidal theta-band alternating current was delivered between the central target electrode and the four return electrodes; polarity reverses continuously during stimulation, so no fixed anode or cathode is present.Sinusoidal 6Hz theta-band tACS was delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasted 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period.
Device: Active 6Hz θ tACS Stimulation

The montage uses one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Sinusoidal theta-band tACS at 6 Hz is delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasts 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. Current polarity reverses continuously during stimulation, so no fixed anode or cathode is defined. Participants continue stable standard clinical care throughout the trial.
Sham Comparator: tACS Stimulation

The sham tACS arm uses the identical electrode montage: one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Each session follows the same 40-minute timeline and identical 30-second ramp-up and 30-second ramp-down procedures as the active stimulation arms. Sinusoidal theta-band current is delivered only during the ramp-up and ramp-down phases. No sustained alternating current is applied for the remainder of the session. All other procedural aspects, including device setup, skin preparation, and participant instructions, are identical to the active arms to preserve masking. Participants continue stable standard clinical care throughout the study.
Device: sham tACS Stimulation

Identical electrode montage (one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7) and the same 40-minute session schedule with 30-second ramp-up and ramp-down periods as the active tACS arms. Sinusoidal current is delivered only during the ramp-up and ramp-down phases. No sustained alternating current is applied for the remainder of the session. All operational procedures, skin preparation, and device appearance are matched to the active arms to maintain masking. Participants continue stable standard clinical care throughout the trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 15
Time Frame: Baseline (Day 0) and Day 15

The Positive and Negative Syndrome Scale (PANSS) is a clinician-rated instrument used to assess positive symptoms, negative symptoms, and general psychopathology in schizophrenia. The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. The primary outcome is the change in PANSS total score from baseline to Day 15, compared between the active and sham groups. Change is calculated as the Day 15 total score minus the baseline total score, with negative values indicating improvement.
Baseline (Day 0) and Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in PANSS Total Score at Days 30 and 56
Time Frame: Baseline (Day 0), Day 15, Day 30, and Day 56

The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. Change at each visit will be calculated as the visit total score minus the baseline total score. Negative changes indicate improvement. Day 30 and Day 56 will be evaluated separately.
Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in PANSS Positive Subscale Score
Time Frame: Baseline (Day 0), Day 15, Day 30, and Day 56

The PANSS positive subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe positive symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement.
Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in PANSS Negative Subscale Score
Time Frame: Baseline (Day 0), Day 15, Day 30, and Day 56

The PANSS negative subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe negative symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement.
Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Total Score
Time Frame: Baseline (Day 0), Day 15, Day 30, and Day 56

The AHRS assesses the severity of auditory hallucinations across seven dimensions. As specified in the protocol, the total score ranges from 0 to 41, with higher scores indicating more severe auditory hallucinations. Change at each visit will be calculated as the visit total score minus the baseline total score; a negative value indicates improvement.
Baseline (Day 0), Day 15, Day 30, and Day 56
Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
Time Frame: Baseline (Day 0), Day 15, Day 30, and Day 56

The HAMD-17 is a 17-item clinician-rated measure of depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement.
Baseline (Day 0), Day 15, Day 30, and Day 56
Changes From Baseline in low-frequency fluctuation (ALFF) of resting-state functional MRI (rs-fMRI) metrics
Time Frame: Baseline (Day 0), Day 15, and Day 56

Changes in resting-state brain functional measure, amplitude of low-frequency fluctuation (ALFF). Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement .
Baseline (Day 0), Day 15, and Day 56
Changes From Baseline in regional homogeneity (ReHo) of resting-state functional MRI (rs-fMRI) metrics
Time Frame: Baseline (Day 0), Day 15, and Day 56

Changes in resting-state brain functional measure, regional homogeneity (ReHo). Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement .
Baseline (Day 0), Day 15, and Day 56
Changes From Baseline in functional connectivity of resting-state functional MRI (rs-fMRI) metrics
Time Frame: Baseline (Day 0), Day 15, and Day 56

Changes in resting-state brain functional measure, functional connectivity (FC) within predefined regions of interest. Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement .
Baseline (Day 0), Day 15, and Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHMU θTACS SCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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