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

November 9, 2020 updated by: Ting Li

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • NIRS assessment for brain death

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult individuals and infants of any gender. Brain damage patients were hired in Beijing Geriatric Hospital, and brain edema patients hired in Tianjin Huanhu Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brain damage patients
Brain damage patients were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager.
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.
Brain edema patients
Brain edema patients were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager.
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.
Healthy subjects
Healthy subjects were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging data
Time Frame: 1 day during the whole experiment
Imaging data collected during the non-contact DCS-Speckle imaging instrument
1 day during the whole experiment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic report fMRI data
Time Frame: 1 day during the whole experiment
Patients' medical record and diagnostic report
1 day during the whole experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ting Li

Collaborators

Beijing Geriatric Hospital
Tianjin Huanhu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brain disease for DCS-Speckle

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Injuries

Clinical Trials on Non-contact DCS-Speckle multi-parameter imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe