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NCT05985993Completed

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

Precise Intervention Technology and Application of Low Intensity Transcranial Ultrasound Stimulation (TUS) on Negative Symptoms of Schizophrenia

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
78 (actual)
First submitted
17 Jul 2023
Start date
1 Apr 2025
Primary completion date
31 Mar 2026
Lead sponsor
Shanghai Mental Health Center
NCT number
NCT05985993

What you commit to

  • Study type: Interventional
  • Participants enrolled: 78
  • From 1 Apr 2025 to the primary completion date, 31 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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;

Other

  • Contraindications to TUS and MRI are present.

Who the study is looking for

  • 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;

Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Mental Health Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.