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Diffusion Tensor Imaging to Judge the Prognosis of Patients With Diffuse Axonal Injury

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ClinicalTrials.gov Identifier: NCT02852109
Recruitment Status : Unknown
Verified July 2016 by Xiaoqiang Wang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaoqiang Wang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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). 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).

Condition or disease
Diffuse Axonal Injury

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).

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Diffusion Tensor Imaging to Judge the Prognosis of Patients With Diffuse Axonal
Study Start Date : September 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Group/Cohort
experimental group
patients who was firstly diagnosed as diffuse axonal injury
control group
patients negative for magnetic resonance examination with no trauma



Primary Outcome Measures :
  1. Change in FA(fractional anisotropy) [ Time Frame: Change from FA(fractional anisotropy) within 2 weeks ]

Secondary Outcome Measures :
  1. Change in ADC(apparent diffusion coefficient) [ Time Frame: Change from ADC(apparent diffusion coefficient) within 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None
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Responsible Party: Xiaoqiang Wang, Associate chief physician, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02852109    
Other Study ID Numbers: XH-16-009
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diffuse Axonal Injury
Wounds and Injuries
Brain Injuries, Diffuse
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System