Clinical trial NCT02171312: Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool
Official title: Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Concussion
Post Concussion Syndrome
Vestibular Neuritis
Keywords: Dizziness
Imbalance
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: National Football League
name: General Electric
name: UnderArmour
First posted: 2014-06-24
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility 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

Primary outcomes:
measure: Simulator Sickness assessed by the Simulator Sickness Questionnaire (SSQ)
timeFrame: Post iDETECT testing (Up to three minutes)
measure: Presence of Post Concussive Symptoms assessed by the Post Concussion Symptoms Scale (PCSS)
timeFrame: Post iDETECT testing (Up to three minutes)
measure: User Experience assessed by the iDETECT User Experience Survey
timeFrame: Post iDETECT testing (Up to three minutes)
Secondary outcomes:
measure: Imbalance assessed by the Balance Error Scoring System (BESS) Score
timeFrame: Visit 0 (Up to ten minutes)
measure: Postural Stability assessed by Quantitative Balance Testing (BioSway) Score
timeFrame: Visit 0 (Up to five minutes)
measure: Visual Acuity assessed by the Dynamic Visual Acuity (DVA) Test
timeFrame: Visit 0 (Up to five minutes)
measure: Vestibular Function assessed by Vestibular/Ocular-Motor Screening (VOMS)
timeFrame: Visit 0 (Up to ten minutes)
measure: Dynamic Gait Ability assessed by Dynamic Gait Index (DGI) Score
timeFrame: Visit 0 (Up to ten minutes)
measure: High Level Balance assessed by the High-level Mobility Assessment Tool (HiMAT)
timeFrame: Visit 0 (Up to ten minutes)
measure: Mobility assessed by the High-level Mobility Assessment Tool (HiMAT)
timeFrame: Visit 0 (Up to ten minutes)
measure: Confidence in Balance assessed by the Activities-specific Balance Confidence (ABC) Scale
timeFrame: Visit 0 (Up to ten minutes)
measure: Dizziness assessed by the Dizziness Handicap Inventory (DHI)
timeFrame: Visit 0 (Up to ten minutes)
measure: Visual Vertigo Symptoms assessed by the Visual Vertigo Analog Scale (VVAS)
timeFrame: Visit 0 (Up to ten minutes)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Sports Concussion Institute
state: Georgia
Study officials:
affiliation: Sports Concussion Institute
name: Russell Gore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: David W Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: