ClinicalTrials.gg
Enrolling by invitationNCT07074704Updated Jul 24, 2025

tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients.

An interventional study of Hi-tACS and Sham Comparison in Negative Symptoms in Schizophrenia and Cognition Function, sponsored by Tongji University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by Tongji University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 247 studies in Schizophrenia with a site in China — 61 open to participants now, 65 under way, 4 of them phase 3. Schizophrenia · China.

Planned enrollment
148th of 212
60 · median 100
Started
2025
with 14 others
No phase
106 of 247
34 open now
Primary completion
2026-02
later than 15 of 64 live
Registered
207th of 247
by date

Among the 247 studies in Schizophrenia with a site in China, this one is the 148th largest by planned enrollment of the 212 interventional ones, is one of 15 that started in 2025, is one of 106 with no phase, reaches primary completion later than 15 of the 64 other live ones, and was the 207th registered.

By phase

247 studies; the count open now beside each. This study's row is marked.

No phasethis study106 · 34 open
Observational35 · 11 open
Phase 335 · 3 open
Phase 433 · 1 open
Phase 122 · 7 open
Phase 210 · 4 open
Phase 1/23 · 1 open
Phase 2/33 · 0 open

By the year they started

First in 2002; this study’s year is marked. 15 started in 2025.

Size and results

Median enrollment 100 across the 212 interventional studies, 300 across the 35 observational. Of the 118 that completed or were terminated, 21 (18%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 247 studies in Schizophrenia with a site in China, or all of them as a file.
02

Study 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. 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
  1. 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.
  2. 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.
03

Conditions studied

  • Negative Symptoms in Schizophrenia
  • Cognition Function

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Inclusion criteria for long-term hospitalized schizophrenia patients:

    1. Diagnosed with schizophrenia and hospitalized for more than half a year
    2. Aged between 18 and 65 years old
    3. Willing to participate in the study and sign the
    4. Stable condition, PANSS total score changed less than 15% at least 2 months before the study.
    5. Education level above primary school
    6. Normal vision or normal after correction

Inclusion criteria for normal control group:

  1. No diagnosed mental illness
  2. Aged between 18 and 65 years old
  3. Willing to participate in the study and sign the informed consent
  4. Education level above primary school
  5. Normal vision or normal after correction
  6. Residents living in Pudong community

Exclusion Criteria:

Exclusion criteria for long-term hospitalization of schizophrenia patients:

  1. Combined diagnosis of other mental illnesses in DSM-5
  2. History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
  3. Severe organic diseases of the heart, liver, kidney and other organs that are unstable
  4. Infectious skin diseases
  5. Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
  6. Pregnant or lactating women
  7. Patients with claustrophobia
  8. Patients with alcohol, drugs Abuse history
  9. Patients who have received TACS treatment in the past and have no effect or intolerance

Exclusion criteria for normal control group:

  1. Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
  2. Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney
  3. Patients with infectious skin diseases
  4. During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
  5. Pregnant or lactating women
  6. Patients with claustrophobia
  7. Patients with a history of alcohol and drug abuse -
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    TACS sham stimulation group

    The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA.

    Device: Sham Comparison

  • Experimental
    tACS Real stimulation group

    The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA.

    Device: Hi-tACS

Interventions

  • DeviceHi-tACS

    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

  • DeviceSham Comparison

    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

06

What researchers measure

Primary outcomes

  1. Eye Tracking

    Binocular saccade amplitude and direction

    Time frame: Day 1 before tACS intervention

  2. Eye Tracking

    Binocular saccade amplitude and direction

    Time frame: Day 1 after tACS intervention

  3. EEG

    resting EEG power spectrum

    Time frame: Day 1 before tACS intervention

  4. EEG

    resting EEG power spectrum

    Time frame: Day 1 after tACS intervention

  5. Brief Negative Symptom Scale (Bnss)

    The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.

    Time frame: Day 1 before tACS intervention

  6. Brief Negative Symptom Scale (Bnss)

    The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.

    Time frame: Day 4 after tACS intervention

  7. 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.

    Time frame: Day 1 before tACS intervention

  8. 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.

    Time frame: Day 4 after tACS intervention

  9. 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.

    Time frame: Day 1 before tACS intervention

  10. 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.

    Time frame: Day 4 after tACS intervention

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Feb 2026, 7 months after the start.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 7 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2025
First posted
Jul 20, 2025
StartActual
Jun 11, 2025
Primary completionEst.
Feb 5, 2026
CompletionEst.
Jun 5, 2026
Last update
Jul 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07074704
Lead sponsor
Tongji University
Responsible party
Weiqing Liu (Dr., Tongji University) — Principal investigator
First posted
Jul 20, 2025
Start date
Jun 11, 2025
Primary completion
Feb 5, 2026 (estimated)
Completion
Jun 5, 2026 (estimated)
Last update
Jul 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion