dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia (NCT07658898) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia
China62 participantsStarted 2026-06-30
Plain-language summary
This randomized, double-blind, sham-controlled trial aims to evaluate the efficacy and safety of dorsal anterior cingulate cortex-targeted temporal interference stimulation in individuals with schizophrenia. Participants will be randomly assigned to receive either active or sham stimulation for 10 sessions over two consecutive weeks. The primary outcome is the change in negative symptoms, assessed using the Negative Symptom Subscale of the Positive and Negative Syndrome Scale. Cognitive performance, detailed dimensions of negative symptoms, psychosocial functioning, quality of life, and treatment-related adverse events will also be evaluated. Neuroimaging assessments will be conducted before and after the intervention to explore potential neural mechanisms underlying the clinical effects of temporal interference stimulation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
. Age between 18 and 65 years, regardless of sex, with completion of at least junior secondary education and the capacity to undergo neurocognitive testing;
. 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;
. 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;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Positive and Negative Syndrome Scale Negative Symptom Subscale Score
Timeframe: Baseline, immediately after the 2-week intervention, and at the 4-week follow-up
Trial details
NCT IDNCT07658898
SponsorShanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
. 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
. 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;
. Current or past substance use disorder, encompassing problematic consumption of alcohol or illicit substances;
. A documented seizure disorder or marked electroencephalographic abnormalities, particularly epileptiform activity;
. Evidence of structural brain pathology, including organic lesions, prior traumatic brain injury, or previous neurosurgical intervention;
. Presence of ferromagnetic implants or any other contraindication to MRI or tTIS exposure, including intracranial metallic clips, implanted cardiac devices, or cochlear implants;
. Current use of glucocorticoids or other pharmacological agents known to meaningfully alter cortical excitability;
. 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.