NCT02370914

Concussion Testing: A Novel Non-invasive Concussion Detection Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Jan Medical, Inc. · Industry
• Sex: Male
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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

Conditions

• Concussion

Interventions

Type	Name	Description
DEVICE	Nautilus NeuroWaveTM System	Recording of subjects with Nautilus NeuroWave diagnostic device
BEHAVIORAL	SCAT	A Neurocognitive evaluation of the patients to assess for concussion.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2015-02-25
• Last updated: 2022-08-02
• Results posted: 2017-04-20

Locations

1 site across 1 country: United States