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TBI MR Study 3 Houston Methodist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218216
Recruitment Status : Terminated (Sponsor terminated study early to start a larger feasability study)
First Posted : August 18, 2014
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Traumatic Brain Injury
Intervention Device: MRI Diagnostic
Enrollment 16
Recruitment Details  
Pre-assignment Details Volunteer Control participants were scanned only for the purpose of operator training and calibrating the MRI device. No data was collected from these participants for the the purpose of analysis.
Arm/Group Title Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Volunteers
Hide Arm/Group Description

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

MRI Diagnostic: 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

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

MRI Diagnostic: 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

MRI Diagnostic of Volunteer Controls for Device Calibration

MRI Diagnostic: 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

Period Title: Overall Study
Started 14 2 3
Completed 8 2 3
Not Completed 6 0 0
Reason Not Completed
Study terminated before completed             6             0             0
Arm/Group Title Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Total
Hide Arm/Group Description

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

MRI Diagnostic: 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

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

MRI Diagnostic: 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

Total of all reporting groups
Overall Number of Baseline Participants 14 2 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 2 participants 16 participants
<=18 years
10
  71.4%
1
  50.0%
11
  68.8%
Between 18 and 65 years
4
  28.6%
1
  50.0%
5
  31.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 2 participants 16 participants
Female
6
  42.9%
0
   0.0%
6
  37.5%
Male
8
  57.1%
2
 100.0%
10
  62.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 2 participants 16 participants
14
 100.0%
2
 100.0%
16
 100.0%
1.Primary Outcome
Title mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
Hide Description 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
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated and no subject outcome data were collected
Arm/Group Title Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Volunteers
Hide Arm/Group Description:

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

MRI Diagnostic: 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

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

MRI Diagnostic: 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

MRI Diagnostic of Volunteer Controls for Device Calibration

MRI Diagnostic: 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

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected during the period of participant enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Volunteer Controls
Hide Arm/Group Description

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

MRI Diagnostic: 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

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

MRI Diagnostic: 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

Non injured volunteers for device calibration

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

All-Cause Mortality
Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Volunteer Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/2 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Volunteer Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/2 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: Diagnostic mTBI Experimental: Diagnostic Non mTBI Volunteer Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/2 (0.00%)      0/3 (0.00%)    
General disorders       
Headache/Dizziness * [1]  1/14 (7.14%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations       
Influenza * [2]  1/14 (7.14%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subject experienced headache/dizziness after MRI
[2]
Subject diagnosed with influenza during the study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer - Head Health Initiative
Organization: GE Healthcare
Phone: 262-544-3633
EMail: Victor.Miranda@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02218216    
Other Study ID Numbers: 114-2014-GES-0046
First Submitted: August 13, 2014
First Posted: August 18, 2014
Results First Submitted: April 27, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017