Clinical trial NCT06231732: The Hi-tACS on Cognitive Function in Patients With Schizophrenia: a Pilot Study
Official title: The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
First posted: 2024-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Meets the diagnostic criteria for schizophrenia according to DSM-5.
2. Age ≥ 18 years old.
3. Right-handed.
4. 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.
5. Clinically stable, receiving antipsychotic medication treatment with a stable dose for 4 weeks without any changes.
6. Montreal Cognitive Assessment score ≥ 10 points.

Exclusion Criteria:

1. 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.
2. Those with severe or unstable organic diseases, with a history of brain tumors or epilepsy.
3. Those who have received MECT or TMS treatment within 1 month before enrollment.
4. Skin integrity at the electrode placement site is compromised. Allergy to electrode gel or adhesive.
5. Implants of metal or electronic devices (such as pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.).
6. Participation in any other clinical trials within 1 month prior to baseline.
7. Pregnant and lactating women.
8. The investigator believes that there are inappropriate conditions for participating in this study.

Primary outcomes:
measure: scores of Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: 30 days of treatment
measure: functional near-infrared spectroscopy
timeFrame: 30 days of treatment
Secondary outcomes:
measure: scores of Montreal Cognitive Assessment Scale
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
measure: scores of Positive and Negative Syndrome Scale
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
measure: scores of Auditory Hallucinations Rating Scale
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
measure: scores of Hamilton Anxiety Scale
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
measure: scores of Hamilton Depression Scale
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
measure: scores of Pittsburgh sleep quality index
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
measure: The Clinical Assessment Interview for Negative Symptoms
timeFrame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Zhejiang Tongde Hospital
state: Zhejiang
Study officials:
References:
citation: Grover S, Fayzullina R, Bullard BM, Levina V, Reinhart RMG. A meta-analysis suggests that tACS improves cognition in healthy, aging, and psychiatric populations. Sci Transl Med. 2023 May 24;15(697):eabo2044. doi: 10.1126/scitranslmed.abo2044. Epub 2023 May 24.
citation: Wang H, Wang K, Xue Q, Peng M, Yin L, Gu X, Leng H, Lu J, Liu H, Wang D, Xiao J, Sun Z, Li N, Dong K, Zhang Q, Zhan S, Fan C, Min B, Zhou A, Xie Y, Song H, Ye J, Liu A, Gao R, Huang L, Jiao L, Song Y, Dong H, Tian Z, Si T, Zhang X, Li X, Kamiya A, Cosci F, Gao K, Wang Y. Transcranial alternating current stimulation for treating depression: a randomized controlled trial. Brain. 2022 Mar 29;145(1):83-91. doi: 10.1093/brain/awab252.