Advanced MRI Applications for Mild Traumatic Brain Injury

NCT02070588 | Terminated Results

• 1 other identifier: 114-2013-GES-0017
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications. Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").

Conditions

Mild Traumatic Brain Injury; Traumatic Brain Injury

Keywords

TBI; mTBI; MR; MRI; Pulse Sequences; NFL

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, Resting State \[RS\] functional magnetic resonance imaging \[fMRI\], kurtosis).

  Per-patient 1 to 3 months, until dataset completion 1 yr

Secondary Outcomes (2)

• Subject Demographics

  Per-patient 1 to 3 months, until dataset completion 1 yr

• Operator Set MRI Parameters

  Per-patient 1 to 3 months, until dataset completion 1 yr

Study Arms (2)

Experimental: Diagnostic mTBI

ACTIVE COMPARATOR

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

Device: MRI

Experimental: Diagnostic Non mTBI

PLACEBO COMPARATOR

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

Device: MRI

Interventions

MRI DEVICE

MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects

Also known as: Discovery MR750 & Discovery MR750w scanners, Investigation software, Comericial nuerological coil (3T Advanced Neurological (Brain) Array MR Coil)

Experimental: Diagnostic Non mTBI; Experimental: Diagnostic mTBI

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may 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.

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)

Hospital for Special Surgery

New York, New York, 08540, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

Victor.Miranda@ge.com

262-544-3633

Study Officials

• Teena Shetty, MD

  Hospital for Special Surgery, New York

  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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)