Negative Symptoms in SchizophreniaCognition Function
Investigational drug(s) / intervention(s)
Hi-tACSSham Comparison
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
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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 -
Primary outcome measure(s)
Eye Tracking — Day 1 before tACS intervention Binocular saccade amplitude and direction
Eye Tracking — Day 1 after tACS intervention Binocular saccade amplitude and direction
EEG — Day 1 before tACS intervention resting EEG power spectrum
EEG — Day 1 after tACS intervention resting EEG power spectrum
Brief Negative Symptom Scale (Bnss) — Day 1 before tACS intervention The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
Brief Negative Symptom Scale (Bnss) — Day 4 after tACS intervention The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
MATRICS Consensus Cognitive Battery，MCCB — 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.
MATRICS Consensus Cognitive Battery，MCCB — 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.
The Clinical Assessment Interview Scale — 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.
The Clinical Assessment Interview Scale — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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