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

NCT ID: NCT07074704

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2026-06-05

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.

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.

Conditions

Negative Symptoms in Schizophrenia; Cognition Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham Comparison

Intervention Type: 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

The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA.

Group Type: EXPERIMENTAL

Hi-tACS

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

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

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Weiqing Liu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PDJWWLZL

Identifier Type: -

Identifier Source: org_study_id