Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool

February 8, 2016 updated by: David Wright, Emory University
The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain injury) system is a novel portable, open access platform that enables immediate and rapid assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT function testing battery with currently used balance and inner ear assessment methods during initial concussion clinic referral. Two groups of participants will be enrolled; a concussion related dizziness cohort and control subjects. The investigators will enroll the concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent dizziness and imbalance symptoms following possible concussion. Healthy control participants will be recruited from the local community. iDETECT's ability to identify post concussion balance/vestibular disturbances will be compared to an expert concussion assessment. Both cohorts will participate in the iDETECT assessment and the clinical assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain injury) system is a novel portable, open access platform that enables immediate and rapid assessment of multimodal neurologic function. This study seeks to evaluate and validate the iDETECT balance, vestibular, and oculomotor testing battery with clinician performed balance and vestibular assessment methods. Two groups of participants will be enrolled; concussion related dizziness cohort and control subjects (no concussion or dizzy symptoms). The investigators will enroll the concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent dizziness and imbalance symptoms following possible concussion. Healthy control participants with normal vestibular function and no history of concussion will be recruited from the local community. All participants will be tested with both the iDETECT balance and vestibular assessment battery and the current clinical reference standards for imbalance and vestibular dysfunction performed by a clinician. Performance on the iDETECT balance and vestibular assessment battery will be compared between normal controls and the concussion cohort.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Sports Concussion Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A cohort of patients presenting to the Sports Concussion Institute with persistent post concussive dizziness and imbalance will be enrolled in this study.

Description

Concussion Cohort

Inclusion Criteria:

  • Age ≥ 12
  • History of concussion within prior 6 months
  • Complaint or symptoms of dizziness / balance problems

Exclusion Criteria:

  • History of any of the following:Depression, sleep apnea, seizure disorder, migraine headaches, prior brain or spine surgery, peripheral neuropathy, lower extremity orthopedic problems
  • Chronic drug or alcohol use; or drug or alcohol use within the previous 24 hours.

Control Cohort

Inclusion Criteria:

  • Age ≥ 12
  • Physically active (at least 60 min of exercise, team-based or recreational, 3 times of week)

Exclusion Criteria:

  • Concussion or concussive-like symptoms within prior 6 months
  • Current complaint or symptoms of dizziness/balance problems
  • History of any of the following:

Depression, sleep apnea, seizure disorder, claustrophobia, prior central nervous system (CNS) surgery, peripheral neuropathy, developmental delay, learning disabilities lower extremity orthopedic problems that prevent standing or walking

  • Participants also cannot currently be the under care of a doctor these or any related conditions that may cause cognitive impairment.
  • Chronic drug or alcohol use; or drug or alcohol use within the previous 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Concussion Cohort
Participants with possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing.
Device: iDETECT Assessment
The iDETECT device is an open platform for an evaluation of cognitive, balance, and oculomotor performance after mild traumatic brain injury (mTBI). It is a rugged, portable, neurocognitive assessment tool designed specifically for use in field and triage settings for the rapid evaluation of functional neurologic impairment after potential concussive injury. The apparatus includes an enhanced heads-up display visor with integration motion detection technology, noise-reducing headphones optimized with pink noise, and a handheld display for test battery administration, subject response inputs, and user data output. iDETECT will be used to assess multimodal neurologic function in participants.
Other Names:
  • integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)
Behavioral: Routine Balance and Vestibular Testing
A clinician will assess balance and vision by standard of care routine tests for neurologic function.
Healthy Controls
Participants without possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing.
Device: iDETECT Assessment
The iDETECT device is an open platform for an evaluation of cognitive, balance, and oculomotor performance after mild traumatic brain injury (mTBI). It is a rugged, portable, neurocognitive assessment tool designed specifically for use in field and triage settings for the rapid evaluation of functional neurologic impairment after potential concussive injury. The apparatus includes an enhanced heads-up display visor with integration motion detection technology, noise-reducing headphones optimized with pink noise, and a handheld display for test battery administration, subject response inputs, and user data output. iDETECT will be used to assess multimodal neurologic function in participants.
Other Names:
  • integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)
Behavioral: Routine Balance and Vestibular Testing
A clinician will assess balance and vision by standard of care routine tests for neurologic function.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Simulator Sickness assessed by the Simulator Sickness Questionnaire (SSQ)
Time Frame: Post iDETECT testing (Up to three minutes)
The Simulator Sickness Questionnaire (SSQ) is a 16-item simulator sickness questionnaire. Participants mark the extent to which they are experiencing various after effects on a scale from 0 to 3 with higher numbers indicating greater severity.
Post iDETECT testing (Up to three minutes)
Presence of Post Concussive Symptoms assessed by the Post Concussion Symptoms Scale (PCSS)
Time Frame: Post iDETECT testing (Up to three minutes)
The Post Concussion Symptoms Scale (PCSS) is a self-report measure with 22 post concussive symptom items graded on a scale from 0 (no symptoms) to 6 (severe symptoms).
Post iDETECT testing (Up to three minutes)
User Experience assessed by the iDETECT User Experience Survey
Time Frame: Post iDETECT testing (Up to three minutes)
The iDETECT User Experience Survey will be used to evaluate participant's experiences with iDETECT as is designed to gather information to help investigators improve the design and effectiveness of iDETECT. It is a thirteen point questionnaire in which participants will rate their experience with the iDETECT tool on a scale from "strongly agree" and "strongly disagree".
Post iDETECT testing (Up to three minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Imbalance assessed by the Balance Error Scoring System (BESS) Score
Time Frame: Visit 0 (Up to ten minutes)
The Balance Error Scoring System (BESS) is a quantitative measure of balance designed for evaluation of imbalance following sports concussion. The BESS is organized into a series of 6 conditions of increasing difficulty. Subjects perform a series of three stances for 20 seconds each standing on either a hard surface or a soft foam surface. Subjects are examined in these six separate conditions with eyes closed. The six balance conditions are; (1) double leg stance, hard surface; (2) single leg stance, hard surface; (3) tandem stance, hard surface; (4) double leg stance, foam surface; (5) single leg stance, foam surface; (6) tandem stance, foam surface. An examiner scores each condition with zero errors representing perfect balance and a maximum of 10 scored errors for each balance condition. The overall score is a composite balance score ranging from zero errors to a maximum score of 60 errors with lower scores representing better balance.
Visit 0 (Up to ten minutes)
Postural Stability assessed by Quantitative Balance Testing (BioSway) Score
Time Frame: Visit 0 (Up to five minutes)
Quantitative Balance Testing (BioSway) provides information about postural stability by measuring subjects sway on a force platform under different conditions. Tests of sensory organization are used to evaluate sensory and postural responses using a series of conditions of increased difficulty.Subjects stand on a force platform that estimates sway in a horizontal antero-posterior direction. Subjects are examined in four separate conditions; (1) eyes open, fixed surface. (2) eyes closed, fixed surface; (3) eyes open, foam surface; (4) eyes closed, foam surface. Each condition is scored according to sway, where 100 is no sway and 0 is a subject fall.
Visit 0 (Up to five minutes)
Visual Acuity assessed by the Dynamic Visual Acuity (DVA) Test
Time Frame: Visit 0 (Up to five minutes)
Dynamic Visual Acuity (DVA) is a measure of visual acuity during head movement using customized computerized software. Visual acuity during head movement will be measured using a computerized system in which subjects read screen based characters while performing horizontal head movements at a target head velocity is between 120 - 180°/sec.
Visit 0 (Up to five minutes)
Vestibular Function assessed by Vestibular/Ocular-Motor Screening (VOMS)
Time Frame: Visit 0 (Up to ten minutes)
The Vestibular/Ocular-Motor Screening (VOMS) is a quantitative measure of vestibular function assessing subjective symptoms when subjects perform a variety of vestibular and oculomotor tasks. VOMS includes symptoms assessments during smooth pursuit, saccades, horizontal and vertical vestibular ocular reflex, near point convergence, and a visual motion sensitivity test.
Visit 0 (Up to ten minutes)
Dynamic Gait Ability assessed by Dynamic Gait Index (DGI) Score
Time Frame: Visit 0 (Up to ten minutes)
The Dynamic Gait Index (DGI) is used to measure dynamic gait stability and fall risk. Scoring of the DGI is based on a 4- point scale from 0 (severe impairment) to 3 (normal ability). A maximum total score of 24 is possible and scores less than 20 indicate fall risk.
Visit 0 (Up to ten minutes)
High Level Balance assessed by the High-level Mobility Assessment Tool (HiMAT)
Time Frame: Visit 0 (Up to ten minutes)
The High-level Mobility Assessment Tool (HiMAT) is used assess high-level balance designed specifically to address the ceiling effect in traumatic brain injury outcome measures. Scoring of the HiMAT is based on performance on eight, timed mobility tasks scored on a 4-point scale with increasing scores representing poor performance on each task. A maximum total score of 32 is possible.
Visit 0 (Up to ten minutes)
Mobility assessed by the High-level Mobility Assessment Tool (HiMAT)
Time Frame: Visit 0 (Up to ten minutes)
The High-level Mobility Assessment Tool (HiMAT) is used assess mobility designed specifically to address the ceiling effect in traumatic brain injury outcome measures. Scoring of the HiMAT is based on performance on eight, timed mobility tasks scored on a 4-point scale with increasing scores representing poor performance on each task. A maximum total score of 32 is possible.
Visit 0 (Up to ten minutes)
Confidence in Balance assessed by the Activities-specific Balance Confidence (ABC) Scale
Time Frame: Visit 0 (Up to ten minutes)
The Activities-specific Balance Confidence (ABC) Scale is used to measure confidence in balance across a continuum of 16 activities including progressively challenging situations from mobility in the home to walking on icy sidewalks.Total scores range from 0 - 100% with baseline scores of < 80% considered abnormal. A significant change in the ABC score is either a return to a score of at least 80% or a change of more than 10 points.
Visit 0 (Up to ten minutes)
Dizziness assessed by the Dizziness Handicap Inventory (DHI)
Time Frame: Visit 0 (Up to ten minutes)
The Dizziness Handicap Inventory (DHI) is a 25-item self-assessment inventory designed to evaluate the self-perceived effects of dizziness. Total scores range from 0 - 100 with higher scores reflecting greater perceived handicap due to dizziness.
Visit 0 (Up to ten minutes)
Visual Vertigo Symptoms assessed by the Visual Vertigo Analog Scale (VVAS)
Time Frame: Visit 0 (Up to ten minutes)
The Visual Vertigo Analog Scale (VVAS) is a nine-item analog scale rating the level of symptoms provoked by daily situations typically inducing visual vertigo.
Visit 0 (Up to ten minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Army Medical Research and Development Command
General Electric
National Football League
UnderArmour

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Russell Gore, MD, Sports Concussion Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00075343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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