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Enrolling by invitation NCT07074704

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

No phase Interventional Negative Symptoms in Schizophrenia Cognition Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hi-tACS, Sham Comparison.
Who it may be relevant to
Registry conditions: Negative Symptoms in Schizophrenia, Cognition Function. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Device Hi-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
  • Device Sham 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

Primary outcome measures

  • Eye Tracking [Time frame: Day 1 before tACS intervention]
  • Eye Tracking [Time frame: Day 1 after tACS intervention]
  • EEG [Time frame: Day 1 before tACS intervention]
  • EEG [Time frame: Day 1 after tACS intervention]
  • Brief Negative Symptom Scale (Bnss) [Time frame: Day 1 before tACS intervention]
  • Brief Negative Symptom Scale (Bnss) [Time frame: Day 4 after tACS intervention]
  • MATRICS Consensus Cognitive Battery，MCCB [Time frame: Day 1 before tACS intervention]
  • MATRICS Consensus Cognitive Battery，MCCB [Time frame: Day 4 after tACS intervention]
  • The Clinical Assessment Interview Scale [Time frame: Day 1 before tACS intervention]
  • The Clinical Assessment Interview Scale [Time frame: Day 4 after tACS intervention]

Eligibility criteria

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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Pudong New Area Mental Health Center — Shanghai

Identifiers

NCT: NCT07074704 · PDJWWLZL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗