Brain InjuriesNCT04623307
Non-contact DCS-Speckle Multi-parameter Imaging for Neurological Diseases
An observational study of Brain Injuries and Brain Edema, run by Ting Li at 1 site in China.
Trial summary
This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Brain Edema, Optical Imaging
- What is being tested?
- Non-contact DCS-Speckle multi-parameter imaging
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
NIRS assessment for brain death
Tianjin, Tianjin Municipality, 300000
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injuries, Brain Edema, Optical Imaging
- Being tested
- Non-contact DCS-Speckle multi-parameter imaging
- Keywords
- DCS-Speckle, Brain injuries, Brain edema
- Medical subject headings
- Brain Injuries, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain damage patients | Brain damage patients were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager. Receives: 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. Receives: 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. Receives: Diagnostic Test: Non-contact DCS-Speckle multi-parameter imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging data
Imaging data collected during the non-contact DCS-Speckle imaging instrument
Measured: 1 day during the whole experiment
Secondary outcomes (1)
Diagnostic report fMRI data
Patients' medical record and diagnostic report
Measured: 1 day during the whole experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ting Li
- Collaborators
- Beijing Geriatric Hospital, Tianjin Huanhu Hospital
- Responsible party
- Sponsor-investigator, Ting Li, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623307
- Sponsor's protocol ID
- Brain disease for DCS-Speckle
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications for Non-contact DCS-Speckle Multi-parameter Imaging for Brain Injuries and Brain Edema
- ClinicalTrials.gov ID
- NCT04623307
- Acronym / sponsor ID
- Brain disease for DCS-Speckle
- Conditions
- Brain Injuries, Brain Edema, Optical Imaging
- Keywords
- DCS-Speckle, Brain injuries, Brain edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ting Li
- Collaborators
- Beijing Geriatric Hospital, Tianjin Huanhu Hospital
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain damage patients | – | Diagnostic Test: Non-contact DCS-Speckle multi-parameter imagingBrain damage patients were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager. |
| Brain edema patients | – | Diagnostic Test: Non-contact DCS-Speckle multi-parameter imagingBrain edema patients were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager. |
| Healthy subjects | – | Diagnostic Test: Non-contact DCS-Speckle multi-parameter imagingHealthy subjects were monitored the human brain activity by the non-contact DCS-Speckle multi-parameter imager. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contact DCS-Speckle multi-parameter imagingThe protocol consists of 2-min resting, 6-min stationary state and 2-min resting, with monitoring data continuously by the DCS-Speckle. | Diagnostic test | Brain damage patients, Brain edema patients, Healthy subjects |
Primary outcome
Imaging data
Time frame: 1 day during the whole experiment
Imaging data collected during the non-contact DCS-Speckle imaging instrument
1 secondary outcome
Diagnostic report fMRI data
Time frame: 1 day during the whole experiment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Brain Edema, run by Ting Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging data (time frame: 1 day during the whole experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.