NCT04620460

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

October 15, 2020

Last Update Submit

August 12, 2021

Conditions

Negative Symptoms of Schizophrenia

Keywords

Low-intensity Focused UltrasoundNegative Symptoms of Schizophrenia Patients

Outcome Measures

Primary Outcomes (2)

  • Clinical Symptoms-PANSS

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

    baseline and 15 days

  • Clinical Symptoms-SANS

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

    baseline and 15 days

Secondary Outcomes (3)

  • Cognitive Function

    baseline, after the fifth treatment and 15 days

  • Change of brain neuroimaging

    baseline, fifth treatment and 15th treatment

  • Cortex Excitability

    baseline，the moment after the intervention, after 15 minutes and 30 minutes

Study Arms (2)

LIFUS-left DLPFC

ACTIVE COMPARATOR

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

Device: Low-intensity Focused Ultrasound(LIFUS)

LIFUS-SHAM

SHAM COMPARATOR

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

Device: Low-intensity Focused Ultrasound(LIFUS)

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.

LIFUS-SHAMLIFUS-left DLPFC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

  • Zhai Z, Ren L, Song Z, Xiang Q, Zhuo K, Zhang S, Li X, Zhang Y, Jiao X, Tong S, Sun J, Liu D. The efficacy of low-intensity transcranial ultrasound stimulation on negative symptoms in schizophrenia: A double-blind, randomized sham-controlled study. Brain Stimul. 2023 May-Jun;16(3):790-792. doi: 10.1016/j.brs.2023.04.021. Epub 2023 Apr 29. No abstract available.

    PMID: 37121354DERIVED

Central Study Contacts

Dengtang LIU

CONTACT

18017311138erliu110@126.com

Qiong Xiang

CONTACT

13817369060xiangqiongxl@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Psychiatrist and Professor

Study Record Dates

First Submitted

October 15, 2020

First Posted

November 9, 2020

Study Start

August 5, 2020

Primary Completion

July 1, 2022

Study Completion

July 31, 2022

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)