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A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion

NCT02660164 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 149

Last updated 2022-06-09

No results posted yet for this study

Summary

The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.

Conditions

  • Concussion

Interventions

DEVICE

Nautilus BrainPulse Recording

Comparison of Nautilus BrainPulse recordings in subjects who have a concussive event (Cohort A) to Nautilus BrainPulse recording in subjects who do not experience a concussive events (Cohort B or matched subjects to Cohort A). Recordings are obtained over a 2 week period every 2 to 3 days (at least 5 recordings per subject).

Sponsors & Collaborators

  • Jan Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Abrams, MD, · University of California San Francisco Medical Center

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660164 on ClinicalTrials.gov