The Hi-tACS on Cognitive Function in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high-frequency transcranial alternating current stimulation, sham high-frequency transcranial alternating current stimulation.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia
Overview
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.
Detailed description
Schizophrenia is a chronic, severe mental disorder characterized by a high suicide rate and significant disability. Cognitive impairment is one of the core symptoms of schizophrenia, with approximately 98% of patients experiencing a decline in cognitive function compared to pre-illness levels. Research has found that individuals with schizophrenia show significant impairments in seven domains, including reaction time, attention, working memory, verbal learning and memory, visual learning and memory, logical reasoning, and social cognition.
Pharmacological treatment remains the primary approach for managing schizophrenia. However, cognitive impairment in individuals with schizophrenia often does not respond well to medication. Additionally, electroconvulsive therapy (ECT) may have potential cognitive side effects. Transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, has been found in several studies to improve cognition. However, its effectiveness is not yet clear.
Conventional tACS utilizes weak currents below 4mA, which can only directly stimulate certain cortical areas and indirectly stimulate deep brain structures. Moreover, the targeting of specific brain regions can be complex, and users may experience a sensation of heat on the skin where the electrodes come into contact.High-frequency transcranial alternating current stimulation (Hi-tACS) employs electrical currents greater than 10mA, typically ranging from 10-15mA. Unlike conventional tACS, Hi-tACS can apply stimulation to the entire brain, potentially enhancing its therapeutic effects. Moreover, Hi-tACS does not require precise targeting and is generally well-tolerated without any discomfort during the stimulation. It is considered a promising and potentially safe treatment modality for cognitive impairment in schizophrenia.
Interventions
- Device high-frequency transcranial alternating current stimulation
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. - Device sham high-frequency transcranial alternating current stimulation
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
Primary outcome measures
- scores of Repeatable Battery for the Assessment of Neuropsychological Status [Time frame: 20 days of treatment]
- functional near-infrared spectroscopy [Time frame: 20 days of treatment]
Secondary outcome measures (9)
- scores of Montreal Cognitive Assessment Scale [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- scores of Positive and Negative Syndrome Scale [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- scores of Auditory Hallucinations Rating Scale [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- scores of Hamilton Anxiety Scale [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- scores of Hamilton Depression Scale [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- scores of Pittsburgh sleep quality index [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- The Clinical Assessment Interview for Negative Symptoms [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
- Magnetic resonance imaging [Time frame: 1 day before the start of the treatment, 20 days of treatment]
- Brain-derived neurotrophic factor [Time frame: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Sir Run Run Shaw Hospital — Hanzhou
- Quzhou Third Hospital — Quzhou
Identifiers
NCT: NCT06470516 · 20230914