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

NCT02171312 | Completed

• 1 other identifier: IRB00075343
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Concussion; Post Concussion Syndrome; Vestibular Neuritis

Keywords

Dizziness; Imbalance

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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".

  Post iDETECT testing (Up to three minutes)

Secondary Outcomes (10)

• Imbalance assessed by the Balance Error Scoring System (BESS) Score

  Visit 0 (Up to ten minutes)

• Postural Stability assessed by Quantitative Balance Testing (BioSway) Score

  Visit 0 (Up to five minutes)

• Visual Acuity assessed by the Dynamic Visual Acuity (DVA) Test

  Visit 0 (Up to five minutes)

• Vestibular Function assessed by Vestibular/Ocular-Motor Screening (VOMS)

  Visit 0 (Up to ten minutes)

• Dynamic Gait Ability assessed by Dynamic Gait Index (DGI) Score

  Visit 0 (Up to ten minutes)

Study Arms (2)

Concussion Cohort

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

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.

Device: iDETECT Assessment; Behavioral: Routine Balance and Vestibular Testing

Interventions

iDETECT Assessment 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.

Also known as: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)

Concussion Cohort; Healthy Controls

Routine Balance and Vestibular Testing BEHAVIORAL

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

Concussion Cohort; Healthy Controls

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• U.S. Army Medical Research and Development Command: collaborator
• National Football League: collaborator
• General Electric: collaborator
• UnderArmour: collaborator

Study Sites (1)

Sports Concussion Institute

Atlanta, Georgia, 30327, United States

Location

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Vestibular Neuronitis; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell Gore, MD

  Sports Concussion Institute

  PRINCIPAL INVESTIGATOR

• David W Wright, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 24, 2014
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2015-10

Locations

US (1)