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

NCT07074704 | Enrolling By Invitation FDA Device

• 1 other identifier: PDJWWLZL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Negative Symptoms in Schizophrenia; Cognition Function

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

TACS sham stimulation group

SHAM COMPARATOR

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

tACS Real stimulation group

EXPERIMENTAL

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

Interventions

Hi-tACS DEVICE

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

tACS Real stimulation group

Sham Comparison DEVICE

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

TACS sham stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with DSM-5 schizophrenia and hospitalized for more than half a year
• Aged between 18 and 65 years old
• Willing to participate in the study and sign the informed consent
• Stable condition, PANSS total score changed less than 15% at least 2 months before the study.
• Education level above primary school
• Normal vision or normal after correction
• No diagnosed mental illness
• Aged between 18 and 65 years old
• Willing to participate in the study and sign the informed consent
• Education level above primary school
• Normal vision or normal after correction
• Residents living in Pudong community

You may not qualify if:

• Combined diagnosis of other mental illnesses in DSM-5
• History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
• Severe organic diseases of the heart, liver, kidney and other organs that are unstable
• Infectious skin diseases
• Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
• Pregnant or lactating women
• Patients with claustrophobia
• Patients with alcohol, drugs Abuse history
• Patients who have received TACS treatment in the past and have no effect or intolerance
• Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
• Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney
• Patients with infectious skin diseases
• During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
• Pregnant or lactating women
• Patients with claustrophobia

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 20, 2025
• Study Start: June 11, 2025
• Primary Completion: February 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)