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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05985993
Other study ID # 2022JC009
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2025

Study information

Verified date August 2023
Source Shanghai Mental Health Center
Contact Dengtang LIU
Phone 021-34773434
Email erliu110@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 neural excitability and plasticity 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. A total of 102 schizophrenia inpatients 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, fNIRS ,and multi-modal MRI 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 102
Est. completion date December 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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; Exclusion Criteria: - 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; - 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; - Contraindications to TUS and MRI are present.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
low-intensity transcranial ultrasound stimulation (TUS)
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).

Locations

Country Name City State
China Shanghai Mental Health Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, 4 weeks and 8 weeks
Primary 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. baseline, 4 weeks and 8 weeks
Secondary Cognitive Function Change from baseline in MATRICS MCCB baseline, 4 weeks and 8 weeks
Secondary Change of Multi-modal Brain Neuroimaging in structure Brain structure data will be acquired. baseline and 4 weeks
Secondary Change of Multi-modal Brain Neuroimaging in resting- state fMRI Resting-state fMRI data will be acquired. baseline and 4 weeks
Secondary Change of Multi-modal Brain Neuroimaging in 1H-MRS 1H-MRS data will be acquired. baseline and 4 weeks
Secondary Change of functional near-infrared spectroscopy (fNIRS) Functional near-infrared spectroscopy (fNIRS), a non-invasive neuroimaging technique that reflects changes in Oxy-Hb and Deoxy-Hb during brain activity, will be measured on left M1 region at baseline to evaluate the neuromodulation effect of TUS on neural activity. baseline
See also
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Withdrawn NCT01234298 - SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia Phase 3
Completed NCT03397134 - Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia Phase 3
Recruiting NCT04620460 - Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia N/A