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.
Negative symptoms is a core symptom of schizophrenia related to poor functional outcome which remains largely treatment refractory. Prior studies indicated that abnormalities in the prefrontal-temporal circuit and glutamate/GABA imbalances may be the root causes of negative symptoms. Transcranial ultrasound stimulation (TUS), an emerging non-invasive neuromodulation technique, can modulate neuroplasticity in the prefrontal and temporal cortex. 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. Schizophrenia inpatients with predominant negative symptoms will be recruited and randomly allocated into single-target group (left DLPFC), both-target group (both left DLPFC and right STG) or sham group in ratio of 1:1:1. This study aims to determine the efficacy of TUS and to reveal its underlying neural mechanism. MEPs, TEPs ,multi-modal MRI and rs-EEG will be detected. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
The rTUS was administered using an immersion-type focused ultrasound transducer (V391-SU, Olympus NDT, Waltham, USA). Low-intensity transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks).
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Change from baseline in the Brief Negative Symptom Scale (BNSS)
Change from baseline in the Brief Negative Symptom Scale (BNSS) at 4 weeks and 8 weeks. The minimum to maximum value is 0-78. Lower scores mean a better outcome.
Time frame: baseline, 4 weeks and 8 weeks
Change from baseline in the Scale for Assessment of Negative Symptoms(SANS)
Change from baseline in the Scale for Assessment of Negative Symptoms(SANS) at 4 weeks and 8 weeks. The minimum to maximum value is 0-120. Lower scores mean a better outcome.
Time frame: baseline, 4 weeks and 8 weeks
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
Change of cognitive Function
Change from baseline in MATRICS MCCB
Time frame: baseline, 4 weeks and 8 weeks
Change of Multi-modal Brain Neuroimaging in structure
Brain structure data will be acquired.
Time frame: baseline and 4 weeks
Change of Multi-modal Brain Neuroimaging in resting- state fMRI
Resting-state fMRI data will be acquired.
Time frame: baseline and 4 weeks
Change of Multi-modal Brain Neuroimaging in 1H-MRS
1H-MRS data will be acquired.
Time frame: baseline and 4 weeks
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Change of EEG microstates
EEG microstates propose that resting-state neural activity is characterized by several globally functional states with specific spatial distributions at sub-second temporal scales. In this study, resting-state 64-channel EEG data were collected from participants before and after rTUS treatment (at baseline and 4 weeks). The aim was to investigate the effects of rTUS on seven types of EEG microstates in individuals with schizophrenia, as well as the association between changes in temporal parameters and psychiatric symptoms before and after treatment. This study seeks to evaluate the overall brain function and temporal dynamics in schizophrenia, as well as the impact of rTUS intervention on the temporal parameters of different microstates.
Time frame: baseline and 4 weeks
Change of TEPs
TMS-evoked potentials (TEPs) from two target regions (the left DLPFC and the right STG) were measured in participants at baseline, after a single TUS intervention, and at 4 weeks. The study aimed to clarify the effects of rTUS treatment on the components of TEPs in individuals with schizophrenia, as well as the association between changes in TEP components and psychiatric symptoms.
Time frame: baseline, Day1, and 4weeks