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An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion

NCT02699346 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-12-22

No results posted yet for this study

Summary

The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and accurately monitor concussed patients with minimal discomfort, potentially providing a new modality for concussion measurement. The device is based on advanced signal analysis algorithms that analyze a very low frequency acoustic signal (within the audible range) generated by the device. The acoustic signal is transmitted using a small transmitter, placed in the participant's ear, and picked by an acoustic sensor placed in the other ear.

Conditions

  • Brain Concussion
  • Brain Injuries

Interventions

DEVICE

HS-1000 recording

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • HeadSense Medical

    lead INDUSTRY

Principal Investigators

  • Allen K Sills, MD · Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-06-30
Completion
2018-03-31

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 NCT02699346 on ClinicalTrials.gov