Efficacy of Hi-tACS for Schizophrenia Negative Symptoms

NCT06888726 | Recruiting FDA Device

• 1 other identifier: 2023-TX-021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Negative Type; Transcranial Alternating Current Stimulation

Keywords

Hi-tACS; Schizophrenia; Randomized Controlled Trial; Negative symptoms

Outcome Measures

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.

  change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)

Secondary Outcomes (11)

• Change in sleep quality of clinical symptom

  change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)

• Change in depression of clinical symptom

  change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)

• Change in anxiety of clinical symptom

  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

  change from baseline (W0) to 3 months after intervention (M3)

• Change in emotion perception of social cognition

  change from baseline (W0) to 3 months after intervention (M3)

Study Arms (2)

intervention group

EXPERIMENTAL

On the basis of maintaining regular medication, the intervention group received continuous Hi-tACS stimulation. The intervention was administered twice daily, in the morning and afternoon, from Monday to Friday for 2 weeks, with each session lasting 40 minutes, totaling 20 sessions.

Device: High-intensity transcranial alternating current stimulation (Hi-tACS)

control group

SHAM COMPARATOR

On the basis of maintaining regular medication, the control group received sham Hi-tACS stimulation, with each stimulation session lasting only 40 seconds. The intervention was administered twice daily, in the morning and afternoon, from Monday to Friday for 2 weeks, with each session lasting 40 minutes, totaling 20 sessions.

Device: Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)

Interventions

High-intensity transcranial alternating current stimulation (Hi-tACS) DEVICE

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 international standard electrode placement system. The stimulation frequency is 77.5 Hz, and the current intensity is 15 mA.

intervention group

Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS) DEVICE

A sham device looks exactly the same as Nexalin ADI is used.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Qing Fan

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Fan, Doctor

CONTACT

18017311322; fanqing_98@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: In this study, the RAND function in Excel is used to generate a random number table to form the random group assignment sequence, which is simple randomization. Interventions are standardized by medical personnel who have passed a training test. Stimulation devices of two groups are identical in appearance. Blinding: The assessors, medical personnel and participants are blinded; the research coordinator assigned the enrolled schizophrenia patients to the Hi-tACS intervention group or the sham stimulation control group based on the randomization table. The assessors, medical personnel and participants are not informed of the treatment group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 21, 2025
• Study Start: June 27, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)