Mild ConcussionNCT02171312
Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool
An observational study of Mild Concussion and Post Concussion Syndrome, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Concussion, Post Concussion Syndrome, Vestibular Neuritis
- What is being tested?
- iDETECT Assessment and Routine Balance and Vestibular Testing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Age ≥ 12
- History of concussion within prior 6 months
- Complaint or symptoms of dizziness / balance problems
- Age ≥ 12
- Physically active (at least 60 min of exercise, team-based or recreational, 3 times of week)
Who cannot join
- 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
- Concussion or concussive-like symptoms within prior 6 months
- Current complaint or symptoms of dizziness/balance problems
- History of any of the following:
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- iDETECT Assessment, Routine Balance and Vestibular Testing
- Keywords
- Dizziness, Imbalance
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Vestibular Neuronitis, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDETECT AssessmentDevice
Also called integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)
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.
Routine Balance and Vestibular TestingBehavioural
A clinician will assess balance and vision by standard of care routine tests for neurologic function.
| Study group | Role | What they receive |
|---|---|---|
| Concussion Cohort | Participants with possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing. Receives: Device: iDETECT Assessment; Behavioral: Routine Balance and Vestibular Testing | |
| Healthy Controls | Participants without possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing. Receives: Device: iDETECT Assessment; Behavioral: Routine Balance and Vestibular Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulator Sickness assessed by the Simulator Sickness Questionnaire (SSQ)
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.
Measured: Post iDETECT testing (Up to three minutes)
Presence of Post Concussive Symptoms assessed by the Post Concussion Symptoms Scale (PCSS)
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).
Measured: Post iDETECT testing (Up to three minutes)
User Experience assessed by the iDETECT User Experience Survey
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".
Measured: Post iDETECT testing (Up to three minutes)
Secondary outcomes (10)
Imbalance assessed by the Balance Error Scoring System (BESS) Score
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.
Measured: Visit 0 (Up to ten minutes)
Postural Stability assessed by Quantitative Balance Testing (BioSway) Score
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.
Measured: Visit 0 (Up to five minutes)
Visual Acuity assessed by the Dynamic Visual Acuity (DVA) Test
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.
Measured: Visit 0 (Up to five minutes)
Vestibular Function assessed by Vestibular/Ocular-Motor Screening (VOMS)
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.
Measured: Visit 0 (Up to ten minutes)
Dynamic Gait Ability assessed by Dynamic Gait Index (DGI) Score
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.
Measured: Visit 0 (Up to ten minutes)
High Level Balance assessed by the High-level Mobility Assessment Tool (HiMAT)
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.
Measured: Visit 0 (Up to ten minutes)
Mobility assessed by the High-level Mobility Assessment Tool (HiMAT)
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.
Measured: Visit 0 (Up to ten minutes)
Confidence in Balance assessed by the Activities-specific Balance Confidence (ABC) Scale
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.
Measured: Visit 0 (Up to ten minutes)
Dizziness assessed by the Dizziness Handicap Inventory (DHI)
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.
Measured: Visit 0 (Up to ten minutes)
Visual Vertigo Symptoms assessed by the Visual Vertigo Analog Scale (VVAS)
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.
Measured: Visit 0 (Up to ten minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild ConcussionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, National Football League, General Electric, UnderArmour
- Responsible party
- Principal investigator, David Wright, Emory University
- Investigators
- Russell Gore, MD, Principal investigator, Sports Concussion InstituteDavid W Wright, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171312
- Sponsor's protocol ID
- IRB00075343
- Status last verified
- Oct 2015
- First submitted
- 19 Jun 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool
- ClinicalTrials.gov ID
- NCT02171312
- Acronym / sponsor ID
- IRB00075343
- Keywords
- Dizziness, Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, National Football League, General Electric, UnderArmour
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion Cohort | – | Device: iDETECT Assessment, Behavioral: Routine Balance and Vestibular TestingParticipants with possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing. |
| Healthy Controls | – | Device: iDETECT Assessment, Behavioral: Routine Balance and Vestibular TestingParticipants without possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age ≥ 12
- History of concussion within prior 6 months
- Complaint or symptoms of dizziness / balance problems
- Age ≥ 12
- Physically active (at least 60 min of exercise, team-based or recreational, 3 times of week)
Key exclusion criteria (9 listed)
- 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
- Concussion or concussive-like symptoms within prior 6 months
- Current complaint or symptoms of dizziness/balance problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDETECT AssessmentAlso: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)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. | Device | Concussion Cohort, Healthy Controls |
| Routine Balance and Vestibular TestingA clinician will assess balance and vision by standard of care routine tests for neurologic function. | Behavioural | Concussion Cohort, Healthy Controls |
Primary outcome
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.
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).
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".
10 secondary outcomes
Imbalance assessed by the Balance Error Scoring System (BESS) Score
Time frame: Visit 0 (Up to ten minutes)
Postural Stability assessed by Quantitative Balance Testing (BioSway) Score
Time frame: Visit 0 (Up to five minutes)
Visual Acuity assessed by the Dynamic Visual Acuity (DVA) Test
Time frame: Visit 0 (Up to five minutes)
Vestibular Function assessed by Vestibular/Ocular-Motor Screening (VOMS)
Time frame: Visit 0 (Up to ten minutes)
Dynamic Gait Ability assessed by Dynamic Gait Index (DGI) Score
Time frame: 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)
Mobility assessed by the High-level Mobility Assessment Tool (HiMAT)
Time frame: 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)
Dizziness assessed by the Dizziness Handicap Inventory (DHI)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Gore, MD principal investigator
Sports Concussion Institute
David W Wright, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Concussion and Post Concussion Syndrome, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulator Sickness assessed by the Simulator Sickness Questionnaire (SSQ) (time frame: Post iDETECT testing (Up to three minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.