Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Mental Health Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.);
Trial design
Design model
Parallel
Treatments tested in this trial
High-intensity transcranial alternating current stimulation (Hi-tACS)
DeviceThe 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 international standard electrode placement system. The stimulation frequency is 77.5 Hz, and the current intensity is 15 mA.
Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)
DeviceA sham device looks exactly the same as Nexalin ADI is used.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: intervention groupExperimental treatment 1 intervention
Group B: control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in negative symptoms of schizophrenia
The primary efficacy evaluation measure is the Positive and Negative Syndrome Scale (PANSS), with statistical parameters including the PANSS total score and the negative subscale score. These scores reflect the severity of schizophrenia symptoms, with higher total or subscale scores indicate more severe symptoms. A decrease in scores after the intervention indicates symptom reduction and effective intervention.
Time frame
change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)Secondary outcomes
1
Change in sleep quality of clinical symptom
The sleep quality assessment measure is Pittsburgh Sleep Quality Index (PSQI). The PSQI is a widely used self-report questionnaire designed to assess sleep quality over a one-month period. The PSQI consists of 19 items, which are grouped into seven components. Each component is scored on a scale from 0 to 3, with higher scores indicating worse sleep quality. The total score ranges from 0 to 21, and a higher total score suggests poorer overall sleep quality. A decrease in the total score after the intervention suggests an improvement in sleep quality.
Time frame
change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)2
Change in depression of clinical symptom
The depression assessment measure is Hamilton Depression Rating Scale (HAMD). The HAMD is a widely used tool for assessing the severity of depression in individuals. The HAMD consists of 17 items. Each item is rated on a scale ranging from 0 to 4 or 0 to 2, with higher scores indicating more severe symptoms. A decrease in the total score after the intervention suggests an improvement in depression.
Time frame
change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)3
Change in anxiety of clinical symptom
The anxiety assessment measure is Hamilton Anxiety Scale (HAMA). The HAMA is a 14-item scale designed to assess the severity of anxiety symptoms in individuals. The total score ranges from 0 to 56, with higher scores indicating greater anxiety severity. A decrease in the total score after the intervention suggests an improvement in anxiety.
Time frame
change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)4
Change in theory of mind of social cognition
The theory of mind assessment measure is faux pas recognition (FPT). The FPT examines the patient's recognition of the faux pas situation of the speaker. Higher total scores on the FTP indicate a better ability to recognize and understand faux pas, as well as stronger empathetic skills. An increase in the total score after the intervention suggests an improvement in theory of mind and social cognition.
Time frame
change from baseline (W0) to 3 months after intervention (M3)Sponsors and contacts
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Source ClinicalTrials.gov