NCT02699346

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

2.4 years

First QC Date

February 26, 2016

Last Update Submit

December 21, 2016

Conditions

Brain ConcussionBrain Injuries

Keywords

concussionmild traumatic brain injuries

Outcome Measures

Primary Outcomes (2)

  • To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects

    20 minute recording session

  • Determine the correlation between ICP measurements obtained from the HS-1000 device and the clinical findings from the modified Balance Error Score System (mBESS) and ImPACT scores in post-concussion patients.

    20 minute recording session

Secondary Outcomes (1)

  • To evaluate the ergonomic and functional aspects of using the HS-1000 by having the operators of the device complete a brief 5 question survey about the ease or difficulty in using the device.

    20 minute recording sessin

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

Eligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed.

Device: HS-1000 recording

Interventions

HS-1000 recordingDEVICE
HS-1000 recording

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy subjects with no previous concussions:
  • Male or female subjects, aged 13 - 25 years old at screening visit
  • Subjects who were previously diagnosed by standard methods as healthy subjects with no previous concussions
  • Subject is able and willing to comply with the requirements of the protocol
  • Subject is able to understand and sign written informed consent to participate in the study
  • Post-concussion diagnosed patients:
  • Male or female subjects, aged 13-25 years at screening visit
  • Subjects who were previously diagnosed by standard methods as suffering from concussion
  • Subject is able and willing to comply with the requirements of the protocol
  • Subject is able to understand and sign written informed consent to participate in the study

You may not qualify if:

  • Local ear infection
  • Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
  • Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
  • Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent
  • History of psychiatric illness, chemical dependency, Attention-Deficit Hyperactivity Disorder (ADHD), Learning Disability, seizure disorder, prior neurosurgical intervention
  • Current use of psychotropic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Brain ConcussionBrain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Allen K Sills, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia Kwiatkowski, M.D.

CONTACT

301-717-2657tricia@head-sense-med.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 4, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

March 1, 2018

Last Updated

December 22, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)