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

Tongji University

Status: Invitation-only

Conditions: Negative Symptoms in Schizophrenia; Cognition Function

Treatments: Device: Sham Comparison; Device: Hi-tACS

Study type: Interventional

Funder types: Other

Identifiers

NCT07074704

PDJWWLZL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

TACS sham stimulation group

Sham Comparator group

Description:

The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA.

Treatment:

Device: Sham Comparison

tACS Real stimulation group

Experimental group

Description:

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

Treatment:

Device: Hi-tACS