NCT06470516

The Hi-tACS on Cognitive Function in Patients With Schizophrenia

The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-03-31
• Completion: 2026-04-01
• First posted: 2024-06-24
• Last updated: 2026-03-02

Locations

2 sites across 1 country: China