Negative Symptoms in SchizophreniaNCT07074704
tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients.
A study testing Hi-tACS in people with Negative Symptoms in Schizophrenia and Cognition Function, run by Tongji University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Negative Symptoms in Schizophrenia, Cognition Function
- What is being tested?
- Hi-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for long-term hospitalized schizophrenia patients:
- Diagnosed with DSM-5 schizophrenia and hospitalized for more than half a year
- Aged between 18 and 65 years old
- Willing to participate in the study and sign the informed consent
- Stable condition, PANSS total score changed less than 15% at least 2 months before the study.
- Education level above primary school
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- Normal vision or normal after correction
- No diagnosed mental illness
- Aged between 18 and 65 years old
- Willing to participate in the study and sign the informed consent
- Education level above primary school
- Normal vision or normal after correction
- Residents living in Pudong community
Who cannot join
- Exclusion criteria for long-term hospitalization of schizophrenia patients:
- Combined diagnosis of other mental illnesses in DSM-5
- History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
- Severe organic diseases of the heart, liver, kidney and other organs that are unstable
- Infectious skin diseases
- Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
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- Pregnant or lactating women
- Patients with claustrophobia
- Patients with alcohol, drugs Abuse history
- Patients who have received TACS treatment in the past and have no effect or intolerance
- Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
- Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney
- Patients with infectious skin diseases
- During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
- Pregnant or lactating women
- Patients with claustrophobia
- Patients with a history of alcohol and drug abuse -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality
About this study
Official title: Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients
This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.
Read the detailed description
- Research purpose (1) This study aims to explore the synergistic therapeutic effect of tACS on negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Using emotion-induced EEG activity in a virtual reality context as a biomarker, analyze its correlation with the clinical efficacy of tACS.
- Expected results (1) It is confirmed that tACS can improve negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Biomarkers can be used to predict the efficacy of tACS in improving negative symptoms and cognitive function in long-term hospitalized schizophrenia patients, and guide clinical precision application.
- Being tested
- Hi-tACS, Sham Comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-tACSDevice
Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days
Sham ComparisonDevice
Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days
| Study group | Role | What they receive |
|---|---|---|
| TACS sham stimulation group | Sham comparator | The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA. Receives: Device: Sham Comparison |
| tACS Real stimulation group | Experimental | The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA. Receives: Device: Hi-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Tracking
Binocular saccade amplitude and direction
Measured: Day 1 before tACS intervention
Eye Tracking
Binocular saccade amplitude and direction
Measured: Day 1 after tACS intervention
EEG
resting EEG power spectrum
Measured: Day 1 before tACS intervention
EEG
resting EEG power spectrum
Measured: Day 1 after tACS intervention
Brief Negative Symptom Scale (Bnss)
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
Measured: Day 1 before tACS intervention
Brief Negative Symptom Scale (Bnss)
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
Measured: Day 4 after tACS intervention
MATRICS Consensus Cognitive Battery，MCCB
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
Measured: Day 1 before tACS intervention
MATRICS Consensus Cognitive Battery，MCCB
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
Measured: Day 4 after tACS intervention
The Clinical Assessment Interview Scale
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
Measured: Day 1 before tACS intervention
The Clinical Assessment Interview Scale
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
Measured: Day 4 after tACS intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start11 Jun 2025
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Symptoms in SchizophreniaStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqing Liu, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074704
- Sponsor's protocol ID
- PDJWWLZL
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT07074704
- Acronym / sponsor ID
- PDJWWLZL
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 20 Jul 2025 (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 aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.
Detailed description
- Research purpose (1) This study aims to explore the synergistic therapeutic effect of tACS on negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Using emotion-induced EEG activity in a virtual reality context as a biomarker, analyze its correlation with the clinical efficacy of tACS.
- Expected results (1) It is confirmed that tACS can improve negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Biomarkers can be used to predict the efficacy of tACS in improving negative symptoms and cognitive function in long-term hospitalized schizophrenia patients, and guide clinical precision application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACS sham stimulation group | Sham comparator | Device: Sham ComparisonThe intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA. |
| tACS Real stimulation group | Experimental | Device: Hi-tACSThe intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Inclusion criteria for long-term hospitalized schizophrenia patients:
- No diagnosed mental illness
- Aged between 18 and 65 years old
- Willing to participate in the study and sign the informed consent
- Education level above primary school
Key exclusion criteria (17 listed)
- Combined diagnosis of other mental illnesses in DSM-5
- History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
- Severe organic diseases of the heart, liver, kidney and other organs that are unstable
- Infectious skin diseases
- Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
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 |
|---|---|---|
| Hi-tACSSham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days | Device | tACS Real stimulation group |
| Sham ComparisonSham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days | Device | TACS sham stimulation group |
Primary outcome
Eye Tracking
Time frame: Day 1 before tACS intervention
Binocular saccade amplitude and direction
Eye Tracking
Time frame: Day 1 after tACS intervention
Binocular saccade amplitude and direction
EEG
Time frame: Day 1 before tACS intervention
resting EEG power spectrum
EEG
Time frame: Day 1 after tACS intervention
resting EEG power spectrum
Brief Negative Symptom Scale (Bnss)
Time frame: Day 1 before tACS intervention
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
Brief Negative Symptom Scale (Bnss)
Time frame: Day 4 after tACS intervention
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
MATRICS Consensus Cognitive Battery，MCCB
Time frame: Day 1 before tACS intervention
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
MATRICS Consensus Cognitive Battery，MCCB
Time frame: Day 4 after tACS intervention
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
The Clinical Assessment Interview Scale
Time frame: Day 1 before tACS intervention
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
The Clinical Assessment Interview Scale
Time frame: Day 4 after tACS intervention
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hi-tACS in people with Negative Symptoms in Schizophrenia and Cognition Function, run by Tongji University 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 13 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 24 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Tracking (time frame: Day 1 before tACS intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.