The Hi-tACS on Cognitive Function in Patients With Schizophrenia
Recruiting · NCT06470516 · Interventional (participants receive a specific treatment) · Lead sponsor: Sir Run Run Shaw Hospital
View the official record on ClinicalTrials.gov →Interventions studied
high-frequency transcranial alternating current stimulationsham high-frequency transcranial alternating current stimulation
What this trial is about
This study is a double-blind, randomized, controlled intervention study aimed at exploring whether high-frequency transcranial alternating current stimulation (Hi-tACS) can improve cognitive impairment in patients with schizophrenia.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Meets the diagnostic criteria for schizophrenia according to DSM-5.
- Age ≥ 18 years old.
- Right-handed.
- Willing to participate in this study and sign an informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, a legal guardian must act as a proxy during the informed consent process and sign the form.
- Clinically stable, receiving antipsychotic medication treatment with a stable dose for 4 weeks without any changes.
- Montreal Cognitive Assessment score ≥ 10 points.
Exclusion criteria
- Psychotic disorders caused by split affective disorder, bipolar disorder, intellectual disability, anxiety spectrum disorders, drugs, alcohol, and other psychoactive substances according to DSM-V diagnostic criteria.
- Those with severe or unstable organic diseases, with a history of brain tumors or epilepsy.
- Those who have received MECT or TMS treatment within 1 month before enrollment.
- Skin integrity at the electrode placement site is compromised. Allergy to electrode gel or adhesive.
- Implants of metal or electronic devices (such as pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.).
- Participation in any other clinical trials within 1 month prior to baseline.
- Pregnant and lactating women.
- The investigator believes that there are inappropriate conditions for participating in this study.
Where it is running
2 locations listed.
- Sir Run Run Shaw Hospital - Hanzhou, Zhejiang, China
- Quzhou Third Hospital - Quzhou, Zhejiang, China