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

• Sponsor: Ting Li (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04623307
• Collaborator: Beijing Geriatric Hospital (Other), Tianjin Huanhu Hospital (Other)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries; Brain Edema; Optical Imaging	Diagnostic Test: Non-contact DCS-Speckle multi-parameter imaging

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Clinical Applications for Non-contact DCS-Speckle Multi-parameter Imaging for Brain Injuries and Brain Edema
• Anticipated Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Imaging data [1 day during the whole experiment]

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

Secondary Outcome Measures

1. Diagnostic report fMRI data [1 day during the whole experiment]

   Patients' medical record and diagnostic report

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NIRS assessment for brain death	Tianjin	Tianjin	China	300000

Sponsors and Collaborators

• Ting Li
• Beijing Geriatric Hospital
• Tianjin Huanhu Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ting Li, Full professor, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04623307
• Other Study ID Numbers: Brain disease for DCS-Speckle
• First Posted: Nov 10, 2020
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ting Li, Full professor, Chinese Academy of Medical Sciences: DCS-Speckle; Brain injuries; Brain edema
• Additional relevant MeSH terms: Brain Injuries; Brain Edema; Edema

Study Results

No Results Posted as of Nov 10, 2020