Efficacy and Mechanisms of TUS on Cognitive Deficits in Schizophrenia: Based on the Hippocampal-Prefrontal Circuit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial ultrasound stimulation.
- Who it may be relevant to
- Registry conditions: Cognitive Deficit in Schizophrenia. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Mechanisms of Transcranial Ultrasound Stimulation (TUS) on Cognitive Deficits in Schizophrenia：Based on the Hippocampal-Prefrontal Circuit
Overview
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.
Detailed description
Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome which remains largely treatment refractory. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/GABA imbalances may be the root causes of cognitive deficits. Transcranial ultrasound stimulation (TUS), an emerging non-invasive neuromodulation technique with deep penetration ability, can modulate neural excitability and plasticity in the hippocampus. This is a 4-week double-blind randomized trial of TUS for cognitive deficits in schizophrenia, with either left hippocampus or left dorsolateral prefrontal cortex (DLPFC) or both targeted. This study aims to determine the efficacy of TUS and to reveal its underlying neural mechanism, especially with the hippocampus-prefrontal circuit, by means of TUS, as to assess cortical inhibition and excitability, EEG source imaging, and multi-model MRI. Neuropsychological assessments will also be conducted to develop the optimized treatment strategy. The study points to a novel and promising therapeutic neuromodulation approach that may improve the functional outcome of schizophrenia, which has been the main cause of mental disability.
Interventions
- Device Transcranial ultrasound stimulation
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).
Primary outcome measures
- Change from baseline in associative memory test score [Time frame: baseline, 4 weeks and 8 weeks]
Secondary outcome measures (8)
- Change of information processing speed and attention/vigilance [Time frame: baseline, 4 weeks and 8 weeks]
- Change of working memory [Time frame: baseline, 4 weeks and 8 weeks]
- Change from baseline in Positive and Negative Syndrome Scale(PANSS) [Time frame: baseline, 4 weeks and 8 weeks]
- Change of CGI score [Time frame: baseline, 4 weeks and 8 weeks]
- Change of Multi-modal Brain Neuroimaging in structure [Time frame: baseline and 4 weeks]
- Change of Multi-modal Brain Neuroimaging in resting- state fMRI [Time frame: baseline and 4 weeks]
- Change of Multi-modal Brain Neuroimaging in 1H-MRS [Time frame: baseline and 4 weeks]
- Change of 64 channels EEG [Time frame: baseline and 4 weeks]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Mental Health Center — Shanghai
Identifiers
NCT: NCT06904092 · 82371504