The Hi-tACS on Cognitive Function in Patients With Schizophrenia: a Pilot Study
The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia: a Pilot Study
Sir Run Run Shaw Hospital
12 participants
Nov 14, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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.
Interventions
The experimental group received real stimulation of high-frequency transcranial alternating current stimulation (Hi-tACS).The treatment duration is 30 days, with two sessions per day, each lasting 40 minutes.The experimental group received Hi-tACS with parameters set at 77.5Hz and 15mA
The the control group received sham stimulation of high-frequency transcranial alternating current stimulation (Hi-tACS).The treatment duration is 30 days, with two sessions per day, each lasting 40 minutes.The experimental group received Hi-tACS with parameters set at 0mA
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06231732