Advanced MRI Applications for Mild Traumatic Brain Injury - UCSF

NCT02141360 | Terminated Results

• 1 other identifier: 114-2014-GES-0001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This hypothesis-generating feasibility study compares mTBI Patients and Controls using advanced MRI Applications.

Conditions

Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software

  To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State \[RS\], functional magnetic resonance imaging \[fMRI\], and additional post-processing modules may be provided

  Baseline to 3 months

Study Arms (2)

Experimental: Diagnostic mTBI

EXPERIMENTAL

MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)

Device: MRI Diagnostic

Experimental: Diagnostic Non mTBI

PLACEBO COMPARATOR

MRI Diagnostic of Non injured subjects that are closely matched to mTBI

Device: MRI Diagnostic

Interventions

MRI Diagnostic DEVICE

Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences

Also known as: Magnetic Resonance Image

Experimental: Diagnostic Non mTBI; Experimental: Diagnostic mTBI

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Subjects will be excluded that have:
• Loss of consciousness (LOC) ≥15 minutes;
• Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;
• Diagnosis of moderate to severe TBI or GCS \<13;
• Structural brain injury indicated by previous neuroimaging findings;
• Previous history of moderate to severe TBI;
• Any previous history of mild TBI within the past 12 months;
• Previously diagnosed brain white matter disease;
• History of seizures within the past 10 years;
• History of self-reported illicit drug abuse (except marijuana) in past 10 years;
• History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
• History of brain mass;
• History of neurosurgery;
• History of stroke;
• History of dementia;

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

University of California at San Francisco (UCSF)

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

Early termination of study due to limited recruitment

Results Point of Contact

• Title: Chief Medical Officer - Head Health Initiative
• Organization: GE Healthcare

Victor.Miranda@ge.com

262-544-3633

Study Officials

• Patrik Mukherjee, MD. PhD

  University of California at San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 19, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)