Trial Outcomes & Findings for Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury (NCT NCT02757053)

Results Overview

MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

within the first two months after the high school football season ends

Results posted on

2018-05-14

Participant Flow

Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination.

Participant milestones

Participant milestones
Measure	Guardian Cap The set of high school football players wearing the Guardian Cap on their helmets Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain	No Guardian Cap The set of high school football players not wearing the Guardian Cap on their helmets
Overall Study STARTED	3	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guardian Cap n=3 Participants The set of high school football players wearing the Guardian Cap on their helmets Guardian Cap: The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain	No Guardian Cap n=5 Participants The set of high school football players not wearing the Guardian Cap on their helmets	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment United States	3 participants n=99 Participants	5 participants n=107 Participants	8 participants n=206 Participants

PRIMARY outcome

Timeframe: within the first two months after the high school football season ends

Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.

MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within the first two months after the high school football season ends

Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.

Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two months of the start of high school football season

Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.

Establish the expected range of MRI Brain SWI and FLAIR lesions in the general high school population at the beginning of a high school football season

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two months of the end of high school football season

Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.

Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players

Outcome measures

Outcome data not reported

Adverse Events

Guardian Cap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Guardian Cap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Development Manager

Heartland Regional Medical Center dba Mosaic Life Care

Phone: 816 271 7937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place