SchizophreniaNCT06231732
The Hi-tACS on Cognitive Function in Patients With Schizophrenia: a Pilot Study
A study testing high-frequency transcranial alternating current stimulation in people with Schizophrenia, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- high-frequency transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Tongde Hospital
Hanzhou, Zhejiang, 310012
Fang Shen, 13957110069, Jek1998@126.com
About this study
Official title: The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia: a Pilot Study
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.
Read the 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
- Being tested
- high-frequency transcranial alternating current stimulation, sham high-frequency transcranial alternating current stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-frequency transcranial alternating current stimulationDevice
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 stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: sham high-frequency transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 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
Measured: 30 days of treatment
Secondary outcomes (7)
scores of Montreal Cognitive Assessment Scale
The Montreal Cognitive Assessment Scale (MoCA) is a cognitive screening tool widely used to assess the cognitive function of individuals. It includes various tasks that evaluate different cognitive domains such as attention, memory, language, and visuospatial abilities. The scoring range for the MoCA is from 0 to 30, with a higher score indicating better cognitive function
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale (PANSS) is a clinical assessment tool used to evaluate symptoms in individuals with psychiatric disorders such as schizophrenia. It assesses positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., reduced emotions, social withdrawal), and general psychopathology (e.g., anxiety, depression). The PANSS consists of 30 items rated on a 7-point scale. It helps clinicians and researchers understand the severity and frequency of symptoms, track changes over time, and evaluate treatment effectiveness.
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Auditory Hallucinations Rating Scale
The Auditory Hallucinations Rating Scale (AHRS) is a standardized assessment tool used to measure the severity and characteristics of auditory hallucinations in individuals with psychiatric conditions. It includes items that assess the frequency, duration, content, and distress associated with auditory hallucinations. The scale provides a quantitative evaluation of these experiences and can be valuable in diagnosis, treatment planning, and outcome evaluation. The AHRS has demonstrated reliability and validity, making it a valuable tool for both research and clinical settings.
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAMA) is a widely used assessment tool for measuring the severity of anxiety symptoms. It consists of 14 items that assess various psychological and physical symptoms of anxiety. The scale is administered through a semi-structured interview, and each item is rated on a scale of 0 to 4 based on symptom severity. The HAM-A is reliable and valid, making it a valuable tool for monitoring symptom changes and evaluating treatment effectiveness in research and clinical settings
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Hamilton Depression Scale
The Hamilton Depression Scale (HAMD) is a widely used assessment tool for measuring the severity of depressive symptoms. It consists of multiple items that assess various psychological and physical symptoms of depression. Each item is rated on a scale of 0 to 4 based on symptom severity. The HAMD is administered through a semi-structured interview and is reliable and valid. It is commonly used in research and clinical settings to monitor symptom changes and evaluate treatment effectiveness.
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI) is a widely used questionnaire for assessing sleep quality in adults. It consists of 19 items that evaluate various aspects of sleep, including subjective quality, duration, efficiency, disturbances, medication use, and daytime dysfunction. The items are rated on a scale of 0 to 3, and the scores are summed for a global score between 0 and 21. The PSQI is a reliable tool used in research and clinical settings to assess sleep quality, including both subjective and objective components. It is a convenient self-administered questionnaire that has been used to measure sleep disturbances and evaluate sleep disorder interventions
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
The Clinical Assessment Interview for Negative Symptoms
The Clinical Assessment Interview for Negative Symptoms (CAINS) means that evaluator uses standardized scale instructions to ask participants specific questions and assess the negative symptoms
Measured: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start14 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Responsible party
- Principal investigator, Jinsong Tang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231732
- Sponsor's protocol ID
- 20231114
- Status last verified
- Jun 2024
- First submitted
- 20 Jan 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37224229Wang 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.
PubMed 35353887
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia: a Pilot Study
- ClinicalTrials.gov ID
- NCT06231732
- Acronym / sponsor ID
- 20231114
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Active comparator | Device: high-frequency transcranial alternating current stimulationThe 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 |
| sham-treatment arm | Sham comparator | Device: sham high-frequency transcranial alternating current stimulationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-frequency transcranial alternating current stimulationThe 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 | treatment arm |
| sham high-frequency transcranial alternating current stimulationThe 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 | Device | sham-treatment arm |
Primary outcome
scores of Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: 30 days of treatment
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.
functional near-infrared spectroscopy
Time frame: 30 days of treatment
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
7 secondary outcomes
scores of Montreal Cognitive Assessment Scale
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Positive and Negative Syndrome Scale
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Auditory Hallucinations Rating Scale
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Hamilton Anxiety Scale
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Hamilton Depression Scale
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
scores of Pittsburgh sleep quality index
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
The Clinical Assessment Interview for Negative Symptoms
Time frame: One day before the start of the treatment, 10 days of treatment, 30 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 37224229Grover 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.
- Background: PubMed 35353887Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-frequency transcranial alternating current stimulation in people with Schizophrenia, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Tang, Doctorate (+8613627311963, tangjinsong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores of Repeatable Battery for the Assessment of Neuropsychological Status (time frame: 30 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06231732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.