Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia

N/AUnknownNCT04620460

Shanghai Mental Health Center40 enrolled

Overview

Based on our research background, we hypothesize that LIFUS has neuromodulation effects on brain cortex and the active LIFUS on left-DLPFC would improve negative symptoms in schizophrenia patients. It would firstly verify the safety of LIFUS on human as well. The multimodal MRI will be contributed to investigate the possible mechanism of negative symptoms.

Firstly, we plan to explore the short-term effects of LIFUS on cortical excitability by detecting the MEP amplitude. 40 patients and relatively well matched healthy-control would be enrolled. After MEP detection and baseline evaluations, the two groups will be treated with one-single intervention on the primary motor cortex. The cognitive function and MEP amplitude will be assessed respectively at the moment, after 15 minutes and 30 minutes. Then, it is a randomized double-blind sham-controlled LIFUS intervention trial in schizophrenia patients. After screening and baseline evaluations, the 40 patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC. The multimodal MRI will be acquired. Clinical symptoms and cognitive function will be assessed respectively at baseline, at the end of fifth treatments and after the end of the treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Negative Symptoms of Schizophrenia

Interventions

Low-intensity Focused Ultrasound(LIFUS)DEVICE

Patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Inclusion Criteria (patients): 1. Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder; 2. Age18-50, right-handed, Han nationality; 3. the score of at least 1 item from N1 to N7 is ≥4 (moderate or above); 4. Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more; 5. Written informed consent; * Exclusion Criteria (patients): 1. Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnant or lactation; 2. Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.; 3. A history of MECT or other physical therapy within 6 months; 4. A history of epilepsy, or epileptic waves on the baseline EEG; 5. 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; 6. Contraindications to LIFUS and MRI are present.

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Clinical Symptoms-PANSS

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

Time frame: baseline and 15 days

Clinical Symptoms-SANS

Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)

Time frame: baseline and 15 days

Secondary Outcomes

Cognitive Function

Change from baseline in the Brief Cognition Test (C-BCT)

Time frame: baseline, after the fifth treatment and 15 days

Change of brain neuroimaging

Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired.

Time frame: baseline, fifth treatment and 15th treatment

Cortex Excitability

MEP amplitude

Time frame: baseline，the moment after the intervention, after 15 minutes and 30 minutes

Central Contacts

Dengtang LIU

CONTACT

18017311138 erliu110@126.com

Qiong Xiang

CONTACT

13817369060 xiangqiongxl@126.com

Data from ClinicalTrials.gov

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