NCT04623307

Brief Summary

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

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

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

November 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

November 9, 2020

Last Update Submit

November 9, 2020

Conditions

Brain InjuriesBrain EdemaOptical Imaging

Keywords

DCS-SpeckleBrain injuriesBrain edema

Outcome Measures

Primary Outcomes (1)

  • Imaging data

    Imaging data collected during the non-contact DCS-Speckle imaging instrument

    1 day during the whole experiment

Secondary Outcomes (1)

  • Diagnostic report fMRI data

    1 day during the whole experiment

Study Arms (3)

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

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

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

Interventions

Non-contact DCS-Speckle multi-parameter imagingDIAGNOSTIC_TEST

The protocol consists of 2-min resting, 6-min stationary state and 2-min resting, with monitoring data continuously by the DCS-Speckle.

Brain damage patientsBrain edema patientsHealthy subjects

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIRS assessment for brain death

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Brain InjuriesBrain Edema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 10, 2020

Study Start

November 1, 2020

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

CN(1)