Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

Traumatic Brain Injury Clinical Trial

— mTBI-phase2  

Official title:

Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556177
• Other study ID #: 114-2015-GES-0017
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

Description:

This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

Subjects included as mTBI patients (Segment 1) will:

1. Be aged =15 and =50 years old at the time of enrollment;

2. Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.

3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.

Subjects included as non-mTBI controls (Segment 2) will:

1. Be aged =15 and =50 years old at the time of enrollment;

2. Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)

3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study.

Exclusion Criteria:

Subjects will be excluded that have: mTBI

1. Loss of consciousness (LOC) =5 minutes;

2. Posttraumatic amnesia lasting =24 hr following mTBI;

3. Current or prior (within past 10 years) moderate to severe TBI

4. Diagnosis of mTBI within the past 6 months;

5. Epilepsy with recurring seizures in past 10 years;

6. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;

7. Alcohol abuse based on AUDIT-C screening;

8. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C

• Screening Axis I/II Disorders):

9. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;

10. Known cognitive dysfunction or structural brain disease/malformation;

11. Structural brain injury on prior neuroimaging findings;

12. Been prescribed antipsychotic/antiepileptic medications;

13. Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

14. Contraindications to MRI scanning, including:

• Current or suspected pregnancy, per site practice;

• Other conditions that may constitute a hazard to the subject during study participation, per investigator;

• Inability to comply with any part of the site's MR safety policy.

Subjects will be excluded that have:- non-TBI (controls)

1. Diagnosis of mTBI within the past 6 months;

2. Prior (within past 10 years) moderate to severe TBI (GCS <13);

3. Epilepsy with recurring seizures in past 10 years;

4. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;

5. Alcohol abuse based on AUDIT-C screening;

6. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C

• Screening Axis I/II Disorders):

7. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;

8. Known cognitive dysfunction or structural brain disease/malformation;

9. Structural brain injury on prior neuroimaging findings;

10. Been prescribed antipsychotic/antiepileptic medications;

11. Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Procedure:
• MRI
MRI scanning

Locations

Country	Name	City	State
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	Universtiy of Miami Health System	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hospital for Special Surgery	New York	New York
United States	University of Pittsburgh Medical College	Pittsburgh	Pennsylvania
United States	University of California-San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI Image Data Sets	MRI image data sets collected from subjects who completed the study.	Per patient scanning over 3 months
Primary	Neuropsychological Assessments	Neuropsychological assessments collected from subjects who completed the study.	Per patient scanning over 3 months