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

Negative Symptoms of Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620460
• Other study ID #: 2020-TX-006
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2021
• Source: Shanghai Mental Health Center
• Contact: Dengtang LIU
• Phone: 18017311138
• Email: erliu110[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Negative Symptoms of Schizophrenia
• Schizophrenia

Intervention

Device:
• Low-intensity Focused Ultrasound(LIFUS)
Patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC.

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	Clinical Symptoms-PANSS	Change from baseline in Positive and Negative Syndrome Scale(PANSS)	baseline and 15 days
Primary	Clinical Symptoms-SANS	Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)	baseline and 15 days
Secondary	Cognitive Function	Change from baseline in the Brief Cognition Test (C-BCT)	baseline, after the fifth treatment and 15 days
Secondary	Change of brain neuroimaging	Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired.	baseline, fifth treatment and 15th treatment
Secondary	Cortex Excitability	MEP amplitude	baseline,the moment after the intervention, after 15 minutes and 30 minutes