TBI MR Study 3 Houston Methodist

NCT02218216 | Terminated Results

• 1 other identifier: 114-2014-GES-0046
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications. The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions. Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor

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 included in the main part of this study (Segment 1) will:
• Be aged ≥15 and ≤50 years old at the time of enrollment;
• Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the first two intervals of the study, as follows:
• Meets criteria for enrollment in Encounter 1 (within 72 hours), or
• Meets criteria for enrollment in Encounter 2 (within 8±2 days)
• Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
• 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;

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Houston Methodist Neurological Institute

Houston, Texas, 77030, 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 due to limited enrollment

Results Point of Contact

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

Victor.Miranda@ge.com

262-544-3633

Study Officials

• Joseph C Masdeu, MD. PhD

  Houston Methodist Neurological Institute

  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: August 13, 2014
• First Posted: August 18, 2014
• Study Start: September 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)