Actively Recruiting
Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for Negative Symptoms in Schizophrenia
Led by Shanghai Mental Health Center · Updated on 2025-06-04
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of high-intensity transcranial alternating current stimulation (Hi-tACS) on negative symptoms in people with schizophrenia. This clinical trial aims to assess whether Hi-tACS is effective and safe, focusing on symptoms as well as cognitive function, social function, and quality of life. The study uses a randomized controlled design involving 60 patients who continue their regular medication while receiving either Hi-tACS or sham stimulation. Participants are divided into two groups: an intervention group that receives continuous Hi-tACS stimulation twice daily (morning and afternoon) from Monday to Friday for 2 weeks, with each session lasting 40 minutes, totaling 20 sessions; and a control group that receives sham stimulation with only 40 seconds of current per session under the same schedule. The Hi-tACS device uses electrodes placed on the forehead and bilateral dorsolateral prefrontal cortex, delivering a 77.5 Hz frequency at 15 mA current intensity. During the study, patients will be assessed at baseline, after 2 weeks of treatment, and again 3 months later. Measurements include changes in negative symptoms, cognitive and social functions, quality of life, and sleep, depression, and anxiety symptoms. Researchers will also evaluate social cognition, neurocognition, and EEG data as part of the outcome measures. The study lasts through these follow-ups to monitor both short-term and longer-term effects of the treatment.
CONDITIONS
Brief Title
Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Han Chinese population
- Age 18 years or older
- Education level of at least 6 years and able to complete questionnaires independently
- Diagnosed with schizophrenia according to DSM-5 criteria assessed by MINI 7.0
- Residual negative symptoms with at least one item scored 2 or higher on PANSS negative subscale (N1-N7)
- Taking stable second-generation atypical antipsychotic medication with no changes in the last 2 weeks
- Patient and guardian consented and signed informed consent form
You will not qualify if you...
- Diagnosed with other mental disorders as per DSM-5
- Total score of 19 or higher on PANSS positive subscale (P1-P7)
- Severe negative symptoms preventing completion of assessments or interventions
- Serious physical or central nervous system diseases such as intracranial infection, tumor, epilepsy, seizures, hydrocephalus, implanted electronic devices, or serious cardiac disease including pacemaker
- Skin problems or hypersensitivity at electrode sites
- Mental retardation (WAIS <70) or severe cognitive impairment (MMSE <24)
- Vision or hearing problems preventing test completion
- Alcohol or drug abuse or dependence
- Pregnancy
- Participation in other clinical studies within past 3 months
- Refusal or failure to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive high-intensity transcranial alternating current stimulation (Hi-tACS) or sham stimulation twice daily, Monday through Friday, for 2 weeks. Each session lasts 40 minutes.
20 sessions over 2 weeks (twice daily, Monday to Friday)
Duration - Approximately 3 months
Participants are assessed for changes in negative symptoms, cognitive function, social function, and quality of life at 3 months after the intervention.
1 follow-up visit at 3 months post-intervention
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Q
Qing Fan, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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