The Hi-tACS on Cognitive Function in Patients With Schizophrenia
NCT Number: NCT06470516
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia
Interventions: DEVICE: high-frequency transcranial alternating current stimulation|DEVICE: sham high-frequency transcranial alternating current stimulation
Sponsor: Sir Run Run Shaw Hospital
Collaborators: Quzhou Third hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2026-04-01
Locations: Sir Run Run Shaw Hospital, Hanzhou, Zhejiang, 310020, China|Quzhou Third Hospital, Quzhou, Zhejiang, 324003, China

Summary:
This study is a double-blind, randomized, controlled intervention study aimed at exploring whether high-frequency transcranial alternating current stimulation (Hi-tACS) can improve cognitive impairment in patients with schizophrenia.

Primary Outcome Measures: scores of Repeatable Battery for the Assessment of Neuropsychological Status, The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a standardized cognitive assessment tool used in clinical and research settings. It evaluates cognitive abilities such as attention, memory, language, and visuospatial skills. The RBANS consists of 12 subtests and takes about 45-60 minutes to complete. It is efficient, providing a comprehensive assessment of cognitive functioning. The RBANS is extensively validated and normed, making it reliable for assessing cognitive performance. It provides standardized scores for comparison with peers, making it useful for detecting cognitive impairments. Overall, the RBANS is a valuable tool for evaluating cognitive functioning and tracking changes over time., 20 days of treatment|functional near-infrared spectroscopy, Functional near-infrared spectroscopy (fNIRS) measures the oxygen content of the cerebral cortex and provides the values of oxy-emoglobin and deoxygenatedhemoglobin in real time, indicating the level of brain activity, 20 days of treatment
Secondary Outcome Measures: scores of Montreal Cognitive Assessment Scale, The Montreal Cognitive Assessment Scale (MoCA) is a cognitive screening tool widely used to assess the cognitive function of individuals. It includes various tasks that evaluate different cognitive domains such as attention, memory, language, and visuospatial abilities. The scoring range for the MoCA is from 0 to 30, with a higher score indicating better cognitive function., 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|scores of Positive and Negative Syndrome Scale, The Positive and Negative Syndrome Scale (PANSS) is a clinical assessment tool used to evaluate symptoms in individuals with psychiatric disorders such as schizophrenia. It assesses positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., reduced emotions, social withdrawal), and general psychopathology (e.g., anxiety, depression). The PANSS consists of 30 items rated on a 7-point scale. It helps clinicians and researchers understand the severity and frequency of symptoms, track changes over time, and evaluate treatment effectiveness., 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|scores of Auditory Hallucinations Rating Scale, The Auditory Hallucinations Rating Scale (AHRS) is a standardized assessment tool used to measure the severity and characteristics of auditory hallucinations in individuals with psychiatric conditions. It includes items that assess the frequency, duration, content, and distress associated with auditory hallucinations. The scale provides a quantitative evaluation of these experiences and can be valuable in diagnosis, treatment planning, and outcome evaluation. The AHRS has demonstrated reliability and validity, making it a valuable tool for both research and clinical settings., 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|scores of Hamilton Anxiety Scale, The Hamilton Anxiety Scale (HAMA) is a widely used assessment tool for measuring the severity of anxiety symptoms. It consists of 14 items that assess various psychological and physical symptoms of anxiety. The scale is administered through a semi-structured interview, and each item is rated on a scale of 0 to 4 based on symptom severity. The HAM-A is reliable and valid, making it a valuable tool for monitoring symptom changes and evaluating treatment effectiveness in research and clinical settings, 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|scores of Hamilton Depression Scale, The Hamilton Depression Scale (HAMD) is a widely used assessment tool for measuring the severity of depressive symptoms. It consists of multiple items that assess various psychological and physical symptoms of depression. Each item is rated on a scale of 0 to 4 based on symptom severity. The HAMD is administered through a semi-structured interview and is reliable and valid. It is commonly used in research and clinical settings to monitor symptom changes and evaluate treatment effectiveness., 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|scores of Pittsburgh sleep quality index, The Pittsburgh Sleep Quality Index (PSQI) is a widely used questionnaire for assessing sleep quality in adults. It consists of 19 items that evaluate various aspects of sleep, including subjective quality, duration, efficiency, disturbances, medication use, and daytime dysfunction. The items are rated on a scale of 0 to 3, and the scores are summed for a global score between 0 and 21. The PSQI is a reliable tool used in research and clinical settings to assess sleep quality, including both subjective and objective components. It is a convenient self-administered questionnaire that has been used to measure sleep disturbances and evaluate sleep disorder interventions, 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|The Clinical Assessment Interview for Negative Symptoms, The Clinical Assessment Interview for Negative Symptoms (CAINS) means that evaluator uses standardized scale instructions to ask participants specific questions and assess the negative symptoms., 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment|Magnetic resonance imaging, Resting state magnetic resonance imaging of the subjects was collected, 1 day before the start of the treatment, 20 days of treatment|Brain-derived neurotrophic factor, Blood samples of the subjects were collected for brain-derived neurotrophic factor, 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment