The Hi-tACS on Cognitive Function in Patients With Schizophrenia

NCT06470516 | Recruiting

• 1 other identifier: 20230914
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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.

  20 days of treatment

• 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

  20 days of treatment

Secondary Outcomes (9)

• scores of Montreal Cognitive Assessment Scale

  1 day before the start of the treatment, 20 days of treatment, 30 days after treatment

• scores of Positive and Negative Syndrome Scale

  1 day before the start of the treatment, 20 days of treatment, 30 days after treatment

• scores of Auditory Hallucinations Rating Scale

  1 day before the start of the treatment, 20 days of treatment, 30 days after treatment

• scores of Hamilton Anxiety Scale

  1 day before the start of the treatment, 20 days of treatment, 30 days after treatment

• scores of Hamilton Depression Scale

  1 day before the start of the treatment, 20 days of treatment, 30 days after treatment

Study Arms (2)

treatment arm

ACTIVE COMPARATOR

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

Device: high-frequency transcranial alternating current stimulation

sham-treatment arm

SHAM COMPARATOR

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

Device: sham high-frequency transcranial alternating current stimulation

Interventions

high-frequency transcranial alternating current stimulation DEVICE

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.

treatment arm

sham high-frequency transcranial alternating current stimulation DEVICE

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

sham-treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Quzhou Third hospital: collaborator
• Taizhou Second People's Hospital: collaborator
• the Seventh Hospital of Shaoxing City: collaborator

Study Sites (2)

Sir Run Run Shaw Hospital

Hanzhou, Zhejiang, 310020, China

RECRUITING

Quzhou Third Hospital

Quzhou, Zhejiang, 324003, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Jinsong Tang, Doctorate

CONTACT

+8613627311963; tangjinsong@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)