tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients.

July 19, 2025 updated by: Weiqing Liu, Tongji University

Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients

This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

  1. Research purpose (1) This study aims to explore the synergistic therapeutic effect of tACS on negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Using emotion-induced EEG activity in a virtual reality context as a biomarker, analyze its correlation with the clinical efficacy of tACS.
  2. Expected results (1) It is confirmed that tACS can improve negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Biomarkers can be used to predict the efficacy of tACS in improving negative symptoms and cognitive function in long-term hospitalized schizophrenia patients, and guide clinical precision application.

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.
60

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Pudong New Area Mental Health Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion criteria for long-term hospitalized schizophrenia patients:

    1. Diagnosed with DSM-5 schizophrenia and hospitalized for more than half a year
    2. Aged between 18 and 65 years old
    3. Willing to participate in the study and sign the informed consent
    4. Stable condition, PANSS total score changed less than 15% at least 2 months before the study.
    5. Education level above primary school
    6. Normal vision or normal after correction

Inclusion criteria for normal control group:

  1. No diagnosed mental illness
  2. Aged between 18 and 65 years old
  3. Willing to participate in the study and sign the informed consent
  4. Education level above primary school
  5. Normal vision or normal after correction
  6. Residents living in Pudong community

Exclusion Criteria:

Exclusion criteria for long-term hospitalization of schizophrenia patients:

  1. Combined diagnosis of other mental illnesses in DSM-5
  2. History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
  3. Severe organic diseases of the heart, liver, kidney and other organs that are unstable
  4. Infectious skin diseases
  5. Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
  6. Pregnant or lactating women
  7. Patients with claustrophobia
  8. Patients with alcohol, drugs Abuse history
  9. Patients who have received TACS treatment in the past and have no effect or intolerance

Exclusion criteria for normal control group:

  1. Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
  2. Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney
  3. Patients with infectious skin diseases
  4. During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
  5. Pregnant or lactating women
  6. Patients with claustrophobia
  7. Patients with a history of alcohol and drug abuse -

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: Quadruple

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.
Sham Comparator: TACS sham stimulation group
The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA.
Device: Sham Comparison
Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days
Experimental: tACS Real stimulation group
The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA.
Device: Hi-tACS
Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days

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
Eye Tracking
Time Frame: Day 1 before tACS intervention
Binocular saccade amplitude and direction
Day 1 before tACS intervention
Eye Tracking
Time Frame: Day 1 after tACS intervention
Binocular saccade amplitude and direction
Day 1 after tACS intervention
EEG
Time Frame: Day 1 before tACS intervention
resting EEG power spectrum
Day 1 before tACS intervention
EEG
Time Frame: Day 1 after tACS intervention
resting EEG power spectrum
Day 1 after tACS intervention
Brief Negative Symptom Scale (Bnss)
Time Frame: Day 1 before tACS intervention
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
Day 1 before tACS intervention
Brief Negative Symptom Scale (Bnss)
Time Frame: Day 4 after tACS intervention
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
Day 4 after tACS intervention
MATRICS Consensus Cognitive Battery，MCCB
Time Frame: Day 1 before tACS intervention
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
Day 1 before tACS intervention
MATRICS Consensus Cognitive Battery，MCCB
Time Frame: Day 4 after tACS intervention
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
Day 4 after tACS intervention
The Clinical Assessment Interview Scale
Time Frame: Day 1 before tACS intervention
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
Day 1 before tACS intervention
The Clinical Assessment Interview Scale
Time Frame: Day 4 after tACS intervention
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
Day 4 after tACS intervention

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.
Tongji 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 (Actual)

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.
June 11, 2025

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.
February 5, 2026

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.
June 5, 2026

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).
June 23, 2025

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.
July 10, 2025

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.
July 20, 2025

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.
July 24, 2025

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.
July 19, 2025

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.
July 1, 2025

More Information

Terms related to this study

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.
  • PDJWWLZL

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

Yes

product manufactured in and exported from the U.S.

Yes

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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