dACC-targeted temporal interference for negative symptoms in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled study enrolling about 74 adults with schizophrenia who have meaningful negative symptoms and cognitive impairment. Participants receive active or sham dACC-targeted temporal interference stimulation over 10 sessions across two weeks, with safety and efficacy monitored through symptom scales, cognitive testing, functional outcomes, and quality of life measures. Neuroimaging before and after the intervention will explore possible neural mechanisms underlying any clinical effects. The trial uses a parallel-group design with outcome assessors blinded to treatment assignment. The intervention is delivered via scalp electrodes and a high-frequency carrier approach to target deep brain regions non-invasively.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All of the following criteria must be satisfied for enrolment:

  1. A confirmed diagnosis of schizophrenia established according to the criteria set forth in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
  2. Age between 18 and 65 years, regardless of sex, with completion of at least junior secondary education and the capacity to undergo neurocognitive testing;
  3. Clinically meaningful negative symptoms, operationalized as a PANSS negative symptom subscale (PANSS-NS) total score ≥ 20 with a rating of ≥ 3 on a minimum of one individual PANSS-NS item ; the PANSS positive symptom subscale score must additionally not exceed 19;
  4. Objective cognitive impairment evidenced by an age- and sex-adjusted composite z-score of ≤ -1.0 on the Chinese version of the Brief Assessment of Cognition in Schizophrenia (BACS), reflecting performance at least one standard deviation below normative values derived from Mandarin-speaking populations;
  5. Maintenance on an unchanged antipsychotic regimen - with no modification to medication type or dose - for at least 30 days prior to informed consent and continuing throughout the trial;
  6. Voluntary agreement to participate, documented by written informed consent following thorough explanation of study objectives and procedures; where applicable, a legally authorized representative may provide or co-sign consent.

Exclusion Criteria:

* Individuals will be ineligible if any of the following conditions apply:

  1. A concurrent psychiatric diagnosis requiring active clinical management, including but not limited to major depressive episode or bipolar disorder, or the presence of a comorbid neurological disorder or serious physical illness;
  2. Current or past substance use disorder, encompassing problematic consumption of alcohol or illicit substances;
  3. A documented seizure disorder or marked electroencephalographic abnormalities, particularly epileptiform activity;
  4. Evidence of structural brain pathology, including organic lesions, prior traumatic brain injury, or previous neurosurgical intervention;
  5. Presence of ferromagnetic implants or any other contraindication to MRI or tTIS exposure, including intracranial metallic clips, implanted cardiac devices, or cochlear implants;
  6. Current use of glucocorticoids or other pharmacological agents known to meaningfully alter cortical excitability;
  7. Prior exposure to any neuromodulatory intervention - including modified electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (TMS), or transcranial direct current stimulation (tDCS) - within the 30 days preceding enrolment.

Where it's running

• Shanghai Pudong New Area Mental Health Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Fan Wu
• Email: butterfly2402@163.com
• Phone: 86+17621766869

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain-derived miRNA biomarkers in first-episode psychosis

  Researchers will test whether specific brain-derived microRNAs in blood can help identify schizophrenia early and track treatment in people with first-episode psychosis on aripiprazole or risperidone.

  Recruiting Northwell Health · Glen Oaks, New York · NCT07703670

• TIS for Improving Cognitive Impairment in Schizophrenia

  A noninvasive brain stimulation study tests whether Temporal Interference Stimulation can improve thinking skills in adults with schizophrenia and cognitive impairment, compared to a sham treatment.

  Recruiting Central South University · Changsha, Hunan · NCT07647380

• Virtual reality mindfulness for reducing aggression in schizophrenia

  We will test whether a virtual reality mindfulness program can help people with schizophrenia or schizoaffective disorder reduce impulsive aggression.

  Recruiting at 2 sites Manhattan Psychiatric Center · New York, New York and 1 other locations · NCT07434479

• Reducing Mental Health Stigma Among Healthcare Workers and Students with a Virtual Reality Protocol

  This study tests a VR protocol to see if putting healthcare workers and students in the first-person experience of psychotic symptoms can reduce explicit and implicit stigma toward schizophrenia.

  Recruiting at 2 sites Centre Hospitalier Henri Laborit · Poitiers and 1 other locations · NCT07375199

• How the schizophrenia brain uses ketones and glucose

  This project will use PET scans to see if ketone and glucose use in the brain changes in people aged 18–35 who are newly diagnosed with schizophrenia before and after starting antipsychotic treatment, compared with healthy controls.

  Recruiting University of Aarhus · Aarhus · NCT07309172

• Cognitive Strategies in Early Psychosis 2 – how brain games and pills test decision making

  This study tests whether a single dose of modafinil or d-serine, compared with placebo, changes decision making in people aged 18–35 who have recently begun experiencing psychosis.

  Recruiting Phase 3 University of Minnesota · Minneapolis, Minnesota · NCT07263022

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.