The Hi-tACS on Cognitive Function in Patients With Schizophrenia
NCT ID: NCT06470516
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-04-01
2026-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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treatment arm
The frequency of the stimulation was 77.5Hz and the intensity was 15mA. Each participant was treated twice a day for 40 minutes each time, with an interval of more than 3 hours between the two sessions for 30 days
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.
sham-treatment arm
The frequency of the stimulation was 77.5Hz and the intensity was 0mA. Each participant was treated twice a day for 40 minutes each time, with an interval of more than 3 hours between the two sessions for 30 days
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Quzhou Third hospital
UNKNOWN
Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Jinsong Tang
Deputy chief physician
Locations
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Sir Run Run Shaw Hospital
Hanzhou, Zhejiang, China
Quzhou Third Hospital
Quzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaofeng Gao
Role: primary
Other Identifiers
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20230914
Identifier Type: -
Identifier Source: org_study_id
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