Trial Outcomes & Findings for Advanced MRI Applications for Mild Traumatic Brain Injury (NCT NCT02070588)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

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

Results posted on

2017-07-21

Participant Flow

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 purpose of analysis.

Participant milestones

Participant milestones
Measure	Experimental: Diagnostic mTBI MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Overall Study STARTED	86	26
Overall Study COMPLETED	47	25
Overall Study NOT COMPLETED	39	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Diagnostic mTBI MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Overall Study Withdrawal by Subject	29	1
Overall Study Writhdrawal due to early termination	9	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Advanced MRI Applications for Mild Traumatic Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Diagnostic mTBI n=86 Participants MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI n=26 Participants MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Volunteers MRI Diagnostic of Volunteer Controls for Device Calibration MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=93 Participants	6 Participants n=4 Participants	0 Participants n=27 Participants	47 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants	20 Participants n=4 Participants	0 Participants n=27 Participants	65 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	13 Participants n=4 Participants	0 Participants n=27 Participants	53 Participants n=483 Participants
Sex: Female, Male Male	46 Participants n=93 Participants	13 Participants n=4 Participants	0 Participants n=27 Participants	59 Participants n=483 Participants
Region of Enrollment United States	86 Participants n=93 Participants	26 Participants n=4 Participants	0 Participants n=27 Participants	112 Participants n=483 Participants

PRIMARY outcome

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

Population: Study was terminated and no subject outcome data were collected

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).

Outcome measures

Outcome measures
Measure	Experimental: Diagnostic mTBI MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Volunteers MRI Diagnostic of Volunteer Controls for Device Calibration MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software	0	0	0

SECONDARY outcome

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

Population: Study was terminated and no subject outcome data were collected

To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.

Outcome measures

Outcome measures
Measure	Experimental: Diagnostic mTBI MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Volunteers MRI Diagnostic of Volunteer Controls for Device Calibration MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Subject Demographics	0	0	0

SECONDARY outcome

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

Population: Study was terminated and no subject outcome data were collected

To record operator-adjusted parameters of the novel software on the MRI system

Outcome measures

Outcome measures
Measure	Experimental: Diagnostic mTBI MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Volunteers MRI Diagnostic of Volunteer Controls for Device Calibration MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Operator Set MRI Parameters	0	0	0

Adverse Events

Experimental: Diagnostic mTBI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Experimental: Diagnostic Non mTBI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: Diagnostic mTBI n=86 participants at risk MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Experimental: Diagnostic Non mTBI n=26 participants at risk MRI Diagnostic of Non injured subjects that are closely matched to mTBI MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects	Volunteers MRI Diagnostic of Volunteer Controls for Device Calibration MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Psychiatric disorders Claustrophobia	1.2% 1/86 • Number of events 1 • Duration of study from enrollment to completion	0.00% 0/26 • Duration of study from enrollment to completion	— 0/0 • Duration of study from enrollment to completion

Additional Information

Chief Medical Officer - Head Health Initiative

GE Healthcare

Phone: 262-544-3633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place