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

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).

Study Overview

• Status: Unknown
• Conditions: 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).

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in FA(fractional anisotropy)	Change from FA(fractional anisotropy) within 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in ADC(apparent diffusion coefficient)	Change from ADC(apparent diffusion coefficient) within 2 weeks

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Diffuse; Brain Injuries; Diffuse Axonal Injury
• Other Study ID Numbers: XH-16-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes