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NCT04623307 Clinical Trial

Non-contact DCS-Speckle Multi-parameter Imaging for Neurological Diseases

Brain Injuries Clinical Trial

Official title:
Clinical Applications for Non-contact DCS-Speckle Multi-parameter Imaging for Brain Injuries and Brain Edema

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04623307
Other study ID # Brain disease for DCS-Speckle
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 31, 2021

Study information
Verified date November 2020
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager.

Description:

Brain injuries includes acute and chronic injuries located in cerebral hemispheres, cerebellum, and brain stem, while brain edema is increased intracellular or extracellular fluid in brain tissue. Early diagnosis is helpful to improve the cure rate and reduce sequelae. This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager, so as to provide reference diagnostic criteria by image artificial intelligence analysis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who have had brain damage. - Patients who have had brain edema. - Healthy people who are interested in non-contact DCS-Speckle multi-parameter imaging Exclusion Criteria: - Patients who are in pregnancy or have plan to conception. - Patients who have vertebra surgery or have plan to surgery. - Patients who are inappropriate to join this trial judged by the radiologists or specialists. - AIDS, Active Hepatitis, Tuberculosis, Syphilis - Patients who regularly take anticoagulants, antiplatelet drugs

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Non-contact DCS-Speckle multi-parameter imaging
The protocol consists of 2-min resting, 6-min stationary state and 2-min resting, with monitoring data continuously by the DCS-Speckle.

Locations
Country Name City State
China NIRS assessment for brain death Tianjin Tianjin

Sponsors (3)
Lead Sponsor Collaborator
Ting Li Beijing Geriatric Hospital, Tianjin Huanhu Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Imaging data Imaging data collected during the non-contact DCS-Speckle imaging instrument 1 day during the whole experiment
Secondary Diagnostic report fMRI data Patients' medical record and diagnostic report 1 day during the whole experiment
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