The Hi-tACS on Cognitive Function in Patients With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Run Run Shaw Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
high-frequency transcranial alternating current stimulation
DeviceThe 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.
sham high-frequency transcranial alternating current stimulation
DeviceThe 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: treatment armActive comparator 1 intervention
Group B: sham-treatment armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
scores of Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a standardized cognitive assessment tool used in clinical and research settings. It evaluates cognitive abilities such as attention, memory, language, and visuospatial skills. The RBANS consists of 12 subtests and takes about 45-60 minutes to complete. It is efficient, providing a comprehensive assessment of cognitive functioning. The RBANS is extensively validated and normed, making it reliable for assessing cognitive performance. It provides standardized scores for comparison with peers, making it useful for detecting cognitive impairments. Overall, the RBANS is a valuable tool for evaluating cognitive functioning and tracking changes over time.
Time frame
20 days of treatment2
functional near-infrared spectroscopy
Functional near-infrared spectroscopy (fNIRS) measures the oxygen content of the cerebral cortex and provides the values of oxy-emoglobin and deoxygenatedhemoglobin in real time, indicating the level of brain activity
Time frame
20 days of treatmentSecondary outcomes
1
scores of Montreal Cognitive Assessment Scale
The Montreal Cognitive Assessment Scale (MoCA) is a cognitive screening tool widely used to assess the cognitive function of individuals. It includes various tasks that evaluate different cognitive domains such as attention, memory, language, and visuospatial abilities. The scoring range for the MoCA is from 0 to 30, with a higher score indicating better cognitive function.
Time frame
1 day before the start of the treatment, 20 days of treatment, 30 days after treatment2
scores of Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale (PANSS) is a clinical assessment tool used to evaluate symptoms in individuals with psychiatric disorders such as schizophrenia. It assesses positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., reduced emotions, social withdrawal), and general psychopathology (e.g., anxiety, depression). The PANSS consists of 30 items rated on a 7-point scale. It helps clinicians and researchers understand the severity and frequency of symptoms, track changes over time, and evaluate treatment effectiveness.
Time frame
1 day before the start of the treatment, 20 days of treatment, 30 days after treatment3
scores of Auditory Hallucinations Rating Scale
The Auditory Hallucinations Rating Scale (AHRS) is a standardized assessment tool used to measure the severity and characteristics of auditory hallucinations in individuals with psychiatric conditions. It includes items that assess the frequency, duration, content, and distress associated with auditory hallucinations. The scale provides a quantitative evaluation of these experiences and can be valuable in diagnosis, treatment planning, and outcome evaluation. The AHRS has demonstrated reliability and validity, making it a valuable tool for both research and clinical settings.
Time frame
1 day before the start of the treatment, 20 days of treatment, 30 days after treatment4
scores of Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAMA) is a widely used assessment tool for measuring the severity of anxiety symptoms. It consists of 14 items that assess various psychological and physical symptoms of anxiety. The scale is administered through a semi-structured interview, and each item is rated on a scale of 0 to 4 based on symptom severity. The HAM-A is reliable and valid, making it a valuable tool for monitoring symptom changes and evaluating treatment effectiveness in research and clinical settings
Time frame
1 day before the start of the treatment, 20 days of treatment, 30 days after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sir Run Run Shaw Hospital
Lead sponsor
Quzhou Third hospital
Collaborator
Taizhou Second People's Hospital
Collaborator
the Seventh Hospital of Shaoxing City
Collaborator
Source ClinicalTrials.gov