Efficacy and Mechanisms of TUS on Cognitive Deficits in Schizophrenia: Based on the Hippocampal-Prefrontal Circuit

NCT06904092 | Not Yet Recruiting

• 1 other identifier: 82371504
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/GABA imbalances may lead to cognitive deficits. Based on the current background and our previous studies, it has been proved that TUS can modulate neural excitability and plasticity in the hippocampus. In this double-blind, randomized study, the efficacy of different treatment options and mechanisms of TUS on cognitive deficits will be investigated.

Conditions

Cognitive Deficit in Schizophrenia

Keywords

Schizophrenia; Cognitive Deficit; Transcranial Ultrasound Stimulation; Hippocampus- Prefrontal Circuit

Outcome Measures

Primary Outcomes (1)

• Change from baseline in associative memory test score

  Change from baseline in the associative memory test score at 4 weeks and 8 weeks.

  baseline, 4 weeks and 8 weeks

Secondary Outcomes (8)

• Change of information processing speed and attention/vigilance

  baseline, 4 weeks and 8 weeks

• Change of working memory

  baseline, 4 weeks and 8 weeks

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

  baseline, 4 weeks and 8 weeks

• Change of CGI score

  baseline, 4 weeks and 8 weeks

• Change of Multi-modal Brain Neuroimaging in structure

  baseline and 4 weeks

Study Arms (4)

single target group : left DLPFC

ACTIVE COMPARATOR

35 eligible patients will be treated with active TUS on the left DLPFC and sham TUS on the left hippocampus for 4 weeks

Device: Transcranial ultrasound stimulation

single target group : left hippocampus

ACTIVE COMPARATOR

35 eligible patients will be treated with active TUS on the left hippocampus and sham TUS on the left DLPFC for 4 weeks

Device: Transcranial ultrasound stimulation

both-target group : left DLPFC and left hippocampus

ACTIVE COMPARATOR

35 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC and left hippocampus

Device: Transcranial ultrasound stimulation

sham TUS group

SHAM COMPARATOR

35 eligible patients will be treated with sham TUS for 4 weeks on the left DLPFC and left hippocampus

Device: Transcranial ultrasound stimulation

Interventions

Transcranial ultrasound stimulation DEVICE

The TUS was administered using Transcranial Ultrasound Stimulator UNS-III (model UNS-III), which has passed the safety test for medical electrical equipment (GB9706.1-2007). Transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks).

both-target group : left DLPFC and left hippocampus; sham TUS group; single target group : left DLPFC; single target group : left hippocampus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the DSM-5 diagnostic criteria for schizophrenia ;
• Age18-50, right-handed, Han nationality;
• Presence of cognitive deficit: defined as d' value \<0.5 in associative memory test;
• Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;
• Written informed consent;

You may not qualify if:

• Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnancy 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 benzodiazepine drugs (diazepam \> 10mg/day, clonazepam \> 2mg/day etc.), if necessary, remain unchanged during the course of treatment;
• Contraindications to TUS and MRI are present.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Central Study Contacts

Dengtang LIU

CONTACT

021-34773434; liudengtang@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)