Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
NCT06888726 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-06-04
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
Interventions
- 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.
Sponsors & Collaborators
-
Shanghai Mental Health Center
lead OTHER
Principal Investigators
-
Qing Fan · Shanghai Mental Health Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-27
- Primary Completion
- 2025-11-30
- Completion
- 2026-11-30
- FDA Device
- Yes
Countries
- China
Study Locations
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