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

ConditionCognitive Deficit in Schizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: single target group : left DLPFCActive comparator 1 intervention
Group B: single target group : left hippocampusActive comparator 1 intervention
Group C: both-target group : left DLPFC and left hippocampusActive comparator 1 intervention
Group D: sham TUS groupSham comparator 1 intervention

Trial outcomes

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.

Time frame
baseline, 4 weeks and 8 weeks

Secondary outcomes

1

Change of information processing speed and attention/vigilance

Change from baseline in 4 MCCB subtests score at 4 weeks and 8 weeks.

Time frame
baseline, 4 weeks and 8 weeks
2

Change of working memory

Change from baseline in N-back task at 4 weeks and 8 weeks. The outcome measures include accuracy, D-prime value, and reaction time.

Time frame
baseline, 4 weeks and 8 weeks
3

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

Change from baseline in Positive and Negative Syndrome Scale(PANSS) at 4 weeks and 8 weeks. The minimum to maximum value is 30-210. Lower scores mean a better outcome.

Time frame
baseline, 4 weeks and 8 weeks
4

Change of CGI score

Change from baseline in Clinical Global Impression (CGI) at 4 weeks and 8 weeks.

Time frame
baseline, 4 weeks and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mental Health Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: