Efficacy of Hi-tACS for Schizophrenia Negative Symptoms

Официальное название

Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia

Обзор

The goal of this clinical trial is to investigate whether Hi-tACS is effective and safe in treating negative symptoms of schizophrenia. Schizophrenic patients will receive treatment (Hi-tACS or shame stimulation) for 2 weeks. Negative symptoms, cognitive functioning, social functioning, and quality of life of intervention group and control group were assessed and compared between the two groups at baseline, 2 weeks, and 3 months post-intervention.

Подробное описание

Objective: To investigate the therapeutic effects and short-term and long-term efficacy of high-intensity transcranial alternating current stimulation (Hi-tACS) on negative symptoms of schizophrenia.

Methods: A randomized controlled design was used, 60 schizophrenic patients who met the enrollment criteria were randomly assigned to either the Hi-tACS intervention group or the sham stimulation control group. Both groups continued their regular medication regimen. The intervention group received continuous current stimulation, while the control group received only 40 seconds of current stimulation per session. The treatment was administered twice daily (morning and afternoon) from Monday to Friday for 2 weeks, with each session lasting 40 minutes, for a total of 20 sessions. Negative symptoms, cognitive function, social function, and quality of life were assessed at baseline, 2 weeks, and 3 months post-intervention.

The primary outcome will be clinical symptoms, the secondary outcome will be the social function and quality of life, and the process measures included social cognition and neurocognition.

Вмешательства

• Устройство High-intensity transcranial alternating current stimulation (Hi-tACS)
  The equipment used is the transcranial microcurrent stimulator (Nexalin ADI), operated by trained therapists following standardized instructions. Three Nexalin conductive electrodes are placed on the patient's head. A 4.45×9.53 cm electrode is placed on the forehead, corresponding to the Fpz region of the 10/20 international standard electrode placement system. Two 3.18×3.81 cm electrodes are placed on the bilateral dorsolateral prefrontal cortex, corresponding to the F3 and F4 regions of the in
• Устройство Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)
  A sham device looks exactly the same as Nexalin ADI is used.

Первичные конечные точки

• Change in negative symptoms of schizophrenia [Срок оценки: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)]

Вторичные конечные точки (11)

• Change in sleep quality of clinical symptom [Срок оценки: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)]
• Change in depression of clinical symptom [Срок оценки: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)]
• Change in anxiety of clinical symptom [Срок оценки: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)]
• Change in theory of mind of social cognition [Срок оценки: change from baseline (W0) to 3 months after intervention (M3)]
• Change in emotion perception of social cognition [Срок оценки: change from baseline (W0) to 3 months after intervention (M3)]
• Change in coping styles of social cognition [Срок оценки: change from baseline (W0) to 3 months after intervention (M3)]
• Change in attributional styles of social cognition [Срок оценки: change from baseline (W0) to 3 months after intervention (M3)]
• Change in neuropsychological status of cognitive function [Срок оценки: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)]
• Change in EEG data of cognitive function [Срок оценки: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)]
• Change in social function [Срок оценки: change from baseline (W0) to 3 months after intervention (M3)]
• Change in quality of life [Срок оценки: change from baseline (W0) to 3 months after intervention (M3)]

Критерии участия

Критерии включения

• Han Chinese population;
• Age ≥ 18 years;
• Education level ≥ 6 years, able to fill out questionnaires on their own, and having sufficient audiovisual level to complete the necessary examinations;
• Meets DSM-5 diagnostic criteria for schizophrenia as assessed by MINI 7.0;
• Residual negative symptoms, with at least one item ≥2 on the negative subscale of PANSS (N1-N7);
• Taking second-generation atypical antipsychotic medication, with no medication or dosage adjustments in the last two weeks
• Patients and guardians agreed to participate in the study and signed an informed consent form.

Критерии исключения

• Meets DSM-5 diagnostic criteria for other mental disorders;
• Total score ≥19 on the PANSS positive subscales (P1-P7) ;
• Severe negative symptoms that prevent the patient from completing the required assessments and interventions;
• Serious physical or central nervous system disease (intracranial infection, intracranial tumor, presence of metal objects in the skull; epilepsy, seizures; history of hydrocephalus or central nervous system tumors; with implanted electronic devices; serious cardiac disease and fitted with a pacemaker, etc.);
• Impaired skin integrity at the site of electrode placement or hypersensitivity to electrode gels or adhesives;
• Mental retardation (Wechsler Adult Intelligence Scale WAIS <70) and/or severe cognitive impairment (Brief Mental State Examination MMSE <24);
• Presence of vision and/or hearing problems that prevent completion of relevant tests;
• Alcohol or drug abuse/dependence;
• Pregnancy;
• Those who have participated or are participating in other clinical studies 3 months ago;
• Failure or refusal to sign the informed consent form.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT06888726 · 2023-TX-021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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