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

NCT02852109 | Unknown DMC

• 1 other identifier: XH-16-009
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diffuse Axonal Injury

Outcome Measures

Primary Outcomes (1)

• Change in FA(fractional anisotropy)

  Change from FA(fractional anisotropy) within 2 weeks

Secondary Outcomes (1)

• Change in ADC(apparent diffusion coefficient)

  Change from ADC(apparent diffusion coefficient) within 2 weeks

Study Arms (2)

experimental group

patients who was firstly diagnosed as diffuse axonal injury

control group

patients negative for magnetic resonance examination with no trauma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diffuse Axonal Injury

Condition Hierarchy (Ancestors)

Brain Injuries, Diffuse; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: August 2, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share