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

Primary Purpose

Negative Symptoms of Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low-intensity Focused Ultrasound(LIFUS)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Negative Symptoms of Schizophrenia focused on measuring Low-intensity Focused Ultrasound, Negative Symptoms of Schizophrenia Patients

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

  • 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

LIFUS-left DLPFC

LIFUS-SHAM

Arm Description

20 patients will be treated with active LIFUS for 3 weeks on the left DLPFC.

20 patients will be treated with sham LIFUS for 3 weeks on the left DLPFC.

Outcomes

Primary Outcome Measures

Clinical Symptoms-PANSS
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Clinical Symptoms-SANS
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)

Secondary Outcome Measures

Cognitive Function
Change from baseline in the Brief Cognition Test (C-BCT)
Change of brain neuroimaging
Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired.
Cortex Excitability
MEP amplitude

Full Information

First Posted
October 15, 2020
Last Updated
August 12, 2021
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04620460
Brief Title
Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia
Official Title
Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative Symptoms of Schizophrenia
Keywords
Low-intensity Focused Ultrasound, Negative Symptoms of Schizophrenia Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LIFUS-left DLPFC
Arm Type
Active Comparator
Arm Description
20 patients will be treated with active LIFUS for 3 weeks on the left DLPFC.
Arm Title
LIFUS-SHAM
Arm Type
Sham Comparator
Arm Description
20 patients will be treated with sham LIFUS for 3 weeks on the left DLPFC.
Intervention Type
Device
Intervention Name(s)
Low-intensity Focused Ultrasound(LIFUS)
Intervention Description
Patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC.
Primary Outcome Measure Information:
Title
Clinical Symptoms-PANSS
Description
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Time Frame
baseline and 15 days
Title
Clinical Symptoms-SANS
Description
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Time Frame
baseline and 15 days
Secondary Outcome Measure Information:
Title
Cognitive Function
Description
Change from baseline in the Brief Cognition Test (C-BCT)
Time Frame
baseline, after the fifth treatment and 15 days
Title
Change of brain neuroimaging
Description
Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired.
Time Frame
baseline, fifth treatment and 15th treatment
Title
Cortex Excitability
Description
MEP amplitude
Time Frame
baseline，the moment after the intervention, after 15 minutes and 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (patients): Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder; Age18-50, right-handed, Han nationality; the score of at least 1 item from N1 to N7 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 (patients): 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.; A history of MECT or other physical therapy within 6 months; A 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 LIFUS and MRI are present.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengtang LIU
Phone
18017311138
Ext
86
Email
erliu110@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiong Xiang
Phone
13817369060
Email
xiangqiongxl@126.com
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dengtang LIU
Phone
18017311138
Email
erliu110@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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