NCT06888726

Efficacy of Hi-tACS for Schizophrenia Negative Symptoms

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Schizophrenia; Negative Type
• Transcranial Alternating Current Stimulation

Interventions

Type	Name	Description
DEVICE	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 international standard electrode placement system. The stimulation frequency is 77.5 Hz, and the current intensity is 15 mA.
DEVICE	Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)	A sham device looks exactly the same as Nexalin ADI is used.

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-11-30
• Completion: 2026-11-30
• First posted: 2025-03-21
• Last updated: 2025-06-04

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study