TIS for Improving Cognitive Impairment in Schizophrenia (NCT07647380) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TIS for Improving Cognitive Impairment in Schizophrenia
China50 participantsStarted 2026-05-30
Plain-language summary
This study aims to evaluate the efficacy, safety, and underlying neural mechanisms of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Researchers will compare active TIS to a sham control to see if TIS works to treat CIAS. Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, E/I imbalance index recorded by EEG, and MRI data, will be collected at baseline, at the end of the 2-week intervention, and 4 weeks after the intervention.
Who can participate
Age range
18 Years – 50 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:
* Age 18-50 years old;
* meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;
* the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
* the disease duration does not exceed 8 years;
* 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed;
* The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%;
* Impaired functioning in daily activities;
* The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above;
* Agree to participate in this study and provide written informed consent
Exclusion Criteria:
* Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco);
* with clear drug-induced extrapyramidal reaction;
* A history of seizures, meningitis, or encephalitis;
* with contraindications to transcranial electrical stimulation;
* History of intracranial tumors or surgery;
* history of severe head trauma;
* have received other regimens of electrical or magnetic therapy in 1 month before enrollment.
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.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to get on a waitlist or check back at a specific time?
2The trial is using a treatment called TIS to target cognitive impairment in schizophrenia and measuring results with something called the MCCB — can you explain what TIS actually involves as a treatment, and what the MCCB is measuring about my cognition?
3Since this trial is listed as Phase NA, which sometimes applies to device or non-drug interventions, can you tell me what's already known about the safety of TIS and whether there are any risks I should understand before considering it?
4Are there existing treatments or therapies for cognitive symptoms of schizophrenia that I should try first, and how would joining a trial like this fit alongside or instead of those options?
5If I were eventually interested in this trial, what would participation actually look like day-to-day — how many visits, how long, and where would I need to go?
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
changes on MCCB scores
Timeframe: Baseline, after 2-week intervention, 4 weeks post-treatment