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NCT Number: NCT07074704

tACS to Improve Negative Symptoms & Cognition 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.

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Key information

Conditions

Negative Symptoms in Schizophrenia Cognition Function

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Normal vision or normal after correction

Inclusion criteria

for normal control group:

  • 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

Exclusion criteria

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
  • 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

Exclusion criteria

for normal control group:

  • 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 -

Treatment and study plan

HI-tACS

Device

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 Comparison

Device

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

Primary outcomes

  1. Eye Tracking

    Time frame: Day 1 before tACS intervention

    Binocular saccade amplitude and direction

  2. Eye Tracking

    Time frame: Day 1 after tACS intervention

    Binocular saccade amplitude and direction

  3. EEG

    Time frame: Day 1 before tACS intervention

    resting EEG power spectrum

  4. EEG

    Time frame: Day 1 after tACS intervention

    resting EEG power spectrum

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Tongji University

Other

Registry information

Official study title

Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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