Concussion Testing: A Novel Non-invasive Concussion Detection Device

Jan Medical

Status: Completed

Conditions: Concussion

Treatments: Behavioral: SCAT; Device: Nautilus NeuroWaveTM System

Study type: Observational

Funder types: Industry

Identifiers

NCT02370914

21114

Details and patient eligibility

About

The purpose of this study is to establish and evaluate a distinctive signal for concussion.

Full description

The purpose of this study is to establish a non-invasive objective measurement for the detection of concussions with the Jan Medical Device (JMD). The study will assess the ability of this device to demonstrate unique signals that correlate with concussions. The study will also test the athletes at baseline at rest and during exertion to determine if there is a difference in the signal from exertion alone. The JMD is a non-invasive band that is placed around the participants head. The JMD detects a unique pattern of signals based on displacement of the skull from changes in blood flow during individual heartbeats. The athletes will be tested longitudinally to assess to changes over time, in addition to changes after impact

Enrollment: 84 patients

Sex: Male

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Junior Varsity and Varsity Players a local High School.

Exclusion criteria

• None

Trial design

84 participants in 2 patient groups

Suspected Concussive Event (SCE)

Description:

When a subject is suspected of a concussion, a Nautilus NeuroWaveTM System recording is obtained from the subject and the recording is evaluated by a Jan Medical concussion algorithm. The subject is declared concussed or not per the algorithm. This is compared to a Sport Concussion Assessment Tool (SCAT) test.

Treatment:

Device: Nautilus NeuroWaveTM System

Behavioral: SCAT

Control

Description:

All subjects at the start of study have a baseline recording using the Nautilus NeuroWaveTM System. These subjects are enrolled into the study as non-concussed and these recordings serve as control recordings. Additionally, some subjects from this cohort will be recorded again at the end of the study to obtain end of season recordings. These results are compared to a Sport Concussion Assessment Tool (SCAT) test.

Treatment:

Device: Nautilus NeuroWaveTM System

Behavioral: SCAT