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

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: Enrolling by invitation
• Conditions: Negative Symptoms in Schizophrenia; Cognition Function
• Intervention / Treatment: Device: Sham Comparison; Device: Hi-tACS

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Eye Tracking	Binocular saccade amplitude and direction	Day 1 before tACS intervention
Eye Tracking	Binocular saccade amplitude and direction	Day 1 after tACS intervention
EEG	resting EEG power spectrum	Day 1 before tACS intervention
EEG	resting EEG power spectrum	Day 1 after tACS intervention
Brief Negative Symptom Scale (Bnss)	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)	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	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	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	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	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

• Sponsor: Tongji University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): February 5, 2026
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID 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