Diffuse Axonal InjuryNCT02852109
Diffusion Tensor Imaging to Judge the Prognosis of Patients With Diffuse Axonal Injury
An observational study of Diffuse Axonal Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diffuse Axonal Injury
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2018
- 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: The patient who attend to be diagnosed as diffuse axonal injury with closed craniocerebral injury caused by a traffic accident or a fall injury)
Who may be able to join
- Has a history of trauma exactly
- Immediate coma after injury
- Increased intracranial pressure level do not agree with clinical illness severity
- No significant changes of CT while with severe clinical manifestations
Who cannot join
- None
About this study
Official title: Diffusion Tensor Imaging to Judge the Prognosis of Patients With Diffuse Axonal
The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.By using fiber tractography the investigators can have the extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).
Read the detailed description
The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.At the same time the investigators rebuild the white matter fiber tract(corpus callosum 、corticospinal tract、optic radiation) of patients using diffusion tensor tractography so that the investigators can judge intuitively the extent of damage and recovery. The investigators Trace the repair of nerve fibers after treatment and guide the further treatment.This trial can exactly determine the relationship between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value in relational interesting area and the extent of damage in patient of DAI（diffuse axonal injury）.Meanwhile the trial confirms that the DTI(diffusion tensor imaging) can exactly judge the prognosis of DAI（diffuse axonal injury）.Obviously by using fiber tractography the investigators can have the extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).
- Conditions
- Diffuse Axonal Injury
- Medical subject headings
- Diffuse Axonal Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | patients who was firstly diagnosed as diffuse axonal injury | |
| control group | patients negative for magnetic resonance examination with no trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FA(fractional anisotropy)
Measured: Change from FA(fractional anisotropy) within 2 weeks
Secondary outcomes (1)
Change in ADC(apparent diffusion coefficient)
Measured: Change from ADC(apparent diffusion coefficient) within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Axonal InjuryStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoqiang Wang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852109
- Sponsor's protocol ID
- XH-16-009
- Status last verified
- Jul 2016
- First submitted
- 15 Apr 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging to Judge the Prognosis of Patients With Diffuse Axonal
- ClinicalTrials.gov ID
- NCT02852109
- Acronym / sponsor ID
- XH-16-009
- Conditions
- Diffuse Axonal Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- 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.
The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.By using fiber tractography the investigators can have the extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).
Detailed description
The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.At the same time the investigators rebuild the white matter fiber tract(corpus callosum 、corticospinal tract、optic radiation) of patients using diffusion tensor tractography so that the investigators can judge intuitively the extent of damage and recovery. The investigators Trace the repair of nerve fibers after treatment and guide the further treatment.This trial can exactly determine the relationship between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value in relational interesting area and the extent of damage in patient of DAI（diffuse axonal injury）.Meanwhile the trial confirms that the DTI(diffusion tensor imaging) can exactly judge the prognosis of DAI（diffuse axonal injury）.Obviously by using fiber tractography the investigators can have the extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –patients who was firstly diagnosed as diffuse axonal injury |
| control group | – | –patients negative for magnetic resonance examination with no trauma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient who attend to be diagnosed as diffuse axonal injury with closed craniocerebral injury caused by a traffic accident or a fall injury)
Key inclusion criteria (4 listed)
- Has a history of trauma exactly
- Immediate coma after injury
- Increased intracranial pressure level do not agree with clinical illness severity
- No significant changes of CT while with severe clinical manifestations
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in FA(fractional anisotropy)
Time frame: Change from FA(fractional anisotropy) within 2 weeks
1 secondary outcome
Change in ADC(apparent diffusion coefficient)
Time frame: Change from ADC(apparent diffusion coefficient) within 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Axonal Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 4 inclusion and 1 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in FA(fractional anisotropy) (time frame: Change from FA(fractional anisotropy) within 2 weeks). 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 2 Aug 2016.