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Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Start Date
June 27, 2024
Primary Completion Date
November 30, 2025
Completion Date
November 30, 2026
Last Updated
June 4, 2025
60
ESTIMATED participants
High-intensity transcranial alternating current stimulation (Hi-tACS)
DEVICE
Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)
DEVICE
Lead Sponsor
Shanghai Mental Health Center
NCT06127056
NCT06026826
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