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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Concussion Post Concussion Syndrome Vestibular Neuritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Concussion Cohort

Participants with possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing.

iDETECT Assessment

Intervention Type DEVICE

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 Testing

Intervention Type BEHAVIORAL

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.

iDETECT Assessment

Intervention Type DEVICE

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 Testing

Intervention Type BEHAVIORAL

A clinician will assess balance and vision by standard of care routine tests for neurologic function.

Interventions

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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.

Intervention Type DEVICE

Routine Balance and Vestibular Testing

A clinician will assess balance and vision by standard of care routine tests for neurologic function.

Intervention Type BEHAVIORAL

Other Intervention Names

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integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)

Eligibility Criteria

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Inclusion Criteria

* 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)

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

* 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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes