Cognition Function, Negative Symptoms in Schizophrenia
Conditions
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.
Interventions
DEVICEHi-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
DEVICESham 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
Sponsors
Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eye Tracking | Day 1 before tACS intervention | Binocular saccade amplitude and direction |
| EEG | Day 1 before 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed