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

Emory University logo

Emory University

Status

Completed

Conditions

Mild Concussion
Vestibular Neuritis
Post Concussion Syndrome

Treatments

Behavioral: Routine Balance and Vestibular Testing
Device: iDETECT Assessment

Study type

Observational

Funder types

Other
Other U.S. Federal agency
Industry

Identifiers

NCT02171312
IRB00075343

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

126 participants in 2 patient groups

Concussion Cohort
Description:
Participants with possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing.
Treatment:
Device: iDETECT Assessment
Behavioral: Routine Balance and Vestibular Testing
Healthy Controls
Description:
Participants without possible concussion related dizziness will complete iDETECT battery testing and routine balance and vestibular testing.
Treatment:
Device: iDETECT Assessment
Behavioral: Routine Balance and Vestibular Testing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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