CompletedNot Applicable

Precise Intervention Technology and Application of Low Intensity TUS on Negative Symptoms of Schizophrenia

China78 participantsStarted 2025-04-01

Plain-language summary

Based on the current background and our previous studies, TUS has been proved that rTUS intervention could induce long-term potentiation like (LTP-like) plasticity and neuromodulate the brain cortex in schizophrenia patients. rTUS over the left dorsolateral prefrontal cortex (DLPFC) can alleviate the negative symptoms in schizophrenia. In this double-blind, randomized, sham-controlled study, the efficacy of different treatment options and mechanisms of low-intensity rTUS on negative symptoms will be investigated.

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: * Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder; * Age18-50, right-handed, Han nationality; * Score of at least 1 item from N1 to N7 in PANSS is ≥4 (moderate or above); * Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more; * Written informed consent; Exclusion Criteria: * Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnant or lactation; * Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.; * History of MECT or other physical therapy within 6 months; * History of epilepsy, or epileptic waves on the baseline EEG; * Ruled out share antiepileptic drugs, carbamazepine, valproic acid salt) or larger doses of benzodiazepines drugs (\> 10 mg/day, diazepam clonazepam 2 mg/day, 1 mg/day, alprazolam lorazepam 2 mg/day, midazolam 10 mg/day, 20 mg/day, Mr Shah diazepam triazolam 0.5 mg/day), avoid the use of chlorine drug, (in principle, to avoid the use of antiepileptic drugs and clonazepam;Other antipsychotic drugs, if necessary, remain unchanged during the course of treatment; * Contraindications to TUS and MRI are present.

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

Change from baseline in the Brief Negative Symptom Scale (BNSS)

Timeframe: baseline, 4 weeks and 8 weeks

Change from baseline in the Scale for Assessment of Negative Symptoms(SANS)

Timeframe: baseline, 4 weeks and 8 weeks

Change from baseline in Positive and Negative Syndrome Scale(PANSS)

Timeframe: baseline, 4 weeks and 8 weeks

Trial details

NCT IDNCT05985993

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Negative Symptoms of Schizophrenia trials

Plain-language summary

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.

What they're measuring

Change from baseline in the Brief Negative Symptom Scale (BNSS)

Timeframe: baseline, 4 weeks and 8 weeks

Change from baseline in the Scale for Assessment of Negative Symptoms(SANS)

Timeframe: baseline, 4 weeks and 8 weeks

Change from baseline in Positive and Negative Syndrome Scale(PANSS)

Timeframe: baseline, 4 weeks and 8 weeks