PWS_Rapid_Assessment_of_Vestibuol-Ocular_Misalignment.pdf

PERFORMANCE WORK STATEMENT

“Refinement of a Portable and Rapid Assessment of Vestibulo-Ocular Misalignment Following Concussion”

1. Background: Traumatic brain injury has been called the signature wound of the wars in Iraq and Afghanistan. Between 42 and 55% of athletes have abnormal oculomotor findings after concussion (Pearce 2015, Howell 2017, DuPrey 2017). In a pediatric cohort with sports-related concussion, vestibulo-ocular dysfunction was present in 30% and was associated with prolonged recovery and predicted post-concussion syndrome (Ellis 2016). Oculomotor deficits after mTBI are predictive of protracted recovery (DuPrey 2017) and can be associated with impaired reaction time (Pearce 2015) and gait (Howell 2017), symptoms that can potentially comprise the lethality and safety of service members. Underscoring the importance of assessing symptoms associated with vestibulo-ocular dysfunction after mTBI, is the addition of the Vestibular/Ocular Motor Screening (Mucha 2014) to the Military Acute Concussion Evaluation 2. Recently, objective behavioral assessments of eye misalignment (i.e., skew deviation) has been validated as critical to differentiating dangerous lesions to the vestibulo-ocular pathways from less serious acute peripheral vestibular disorders (Schubert 2017; Kattah 2009). These diagnoses have very different clinical presentations and trajectories, and early identification will optimize medical management and speed return to duty.

Assessing and measuring eye misalignment (skew deviation) is currently limited to techniques that fail to measure both horizontal and vertical components, often ignore the relevant torsional component, or require equipment that cannot be used in austere environments (Awadein 2013). Our previous efforts have led to the development of a portable, handheld, binocular and objective means to assess eye misalignment called vertical alignment nulling (VAN) and torsional alignment nulling (TAN) (Beaton 2017). The hand-held, portable nature and rapid self-assessment capabilities make VAN and TAN ideally suited for military medicine as a means to quantify vestibulo-ocular performance and eye misalignment. An operational challenge with our existing device is that assessments must be performed in darkness, either in a dark room or under a shroud. This makes the test less portable and rapid. Our work here attempts to solve this problem, with the expectation of delivering a portable, valid, ruggedized device that assesses ocular alignment. We will leverage commercially available hardware (i.e., Google daydream, $45) and smartphones with custom software applications that provide a valid measure of VAN and TAN. For example, the Google Daydream hardware is a Head Mounted Display (HMD) that eliminates light pollution and contains a pocket to place a smartphone. We will develop a virtual reality software application of VAN and TAN (vrVAN, vrTAN) to be used with the HMD. In summary, the current proposal seeks to build on our previous work and improve portability in order to better measure the important signs associated with protracted recovery following mTBI. Improved measurement of vestibulo-ocular performance and eye misalignment may better inform assessment and management of mTBI, but first we must have a means to rapidly and easily measure VAN and TAN.

1.1 Description of Effort: The Contractor shall develop a virtual reality version of VAN and

TAN using existing off the shelf hardware and custom software. The Contractor shall then validate the new version against its current analog counterpart through a proof-of-concept procedure among approximately 20 individuals with central (mild traumatic brain injury) and/or peripheral vestibular disorders.

2. Objectives: This research will develop a virtual reality method to enable VAN and TAN testing in lighted environments with a portable, affordable, and readily available technology that ensures darkness while we assess vestibulo-ocular performance and eye misalignment.

This will allow for streamlined, accurate testing. In order to apply these techniques in the clinical environment (civilian and military), a valid and reliable platform that is field-expedient must be developed to effectively and efficiently perform VAN and TAN.

Tasks:

2.1 The Contractor shall develop a virtual reality version of VAN and TAN using existing off the shelf hardware and custom software.

2.2 The Contractor shall validate the new version against its current analog counterpart through a proof-of-concept procedure among approximately 20 individuals with central (mild traumatic brain injury) and/or peripheral vestibular disorders.

2.3 The Contractor is responsible for providing all personnel and equipment necessary for completing this effort. The Contractor shall examine vrVAN, vrTAN, VAN, and TAN in patients with vestibular schwannoma resection as they often have an acute ocular misalignment, that recovers typically within 7 days. The design to study ocular misalignment in vestibular surgical patients enables the Contractor to measure both the acute misalignment and recovery of ocular alignment. The Contractor shall also measure vrVAN, vrTAN, VAN, and TAN in patients with central disorders that commonly affecting ocular misalignment including mild traumatic brain injury.

3. Contractor Key Personnel: The Contractor shall provide a Doctoral Student at 0.45 FTE. The

Doctoral Student will assist with performance of all aspects of the study, including consenting subjects and collecting data. The Research Assistant shall also meet with the Government’s Technical Point of Contact and Government research team on a monthly basis to review planning and execution of the protocol. The Contractor shall provide the expertise of Dr. Michael Schubert at 0.10 FTE, Dr. Mark Shelhamer (who patented the SARA technique for portable assessment) at 0.10 FTE, and Dr. Dan Gold at 0.05 FTE. This expert team will assist with performance of all aspects of the study.

3.1 Contractor Personnel: The Contractor shall provide a Contracts Manager who shall be responsible for the performance of the work completed by Contractor employees. The name of this person and an alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the Contracting Officer. The Contracts Manager or alternate shall be available between 9:00 a.m. to 5:30 p.m. Central Standard Time, Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

3.2 The Contractor’s representative shall meet with the Government’s Technical Point of Contact (TPOC) via telephone or video conference when requested by the TPOC to discuss any problems that the Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and a resolution plan will be established. Unresolved problems will be referred to the Contracting Officer for resolution. Meetings shall be via teleconference unless an alternate method is agreed upon prior to the meeting date.

NOTE - All regulations referenced are available for review from the TPOC, military facility, or the Contracting Officer. The Contractor shall comply with all military facility policies, also including appearance and conduct. The Contractor shall maintain a neat, well-groomed appearance at all times to facilitate credibility. Tank tops, halter tops, clothing with alcohol, drug, tobacco or profane related messages/slogans/trademarks, shorts, jeans, or t-shirts shall not be worn.

Uniformed military personnel and Government civilian employees will not be employed to perform services under this agreement without prior approval from the COR and the appropriate approval obtained using a request for off-duty employment.

4. Research Personnel

4.1 The Contractor shall be able to work well independently and identify work priorities to meet protocol(s) timelines.

4.2 The Contractor shall be responsible for the day-to-day conduct of the project(s) and shall answer research questions by executing the routine functions of the research study/studies and by providing administrative oversight of the project(s) to ensure that it is executed successfully.

4.3 The Contractor shall execute study protocol(s) according to the methods and procedures as outlined in the AAMTI RFI proposal and as directed by the Primary Investigator, who is government personnel.

4.4 The Contractor shall communicate with the Government’s research team(s) concerning the study via email, team meetings, and phone contact.

5. Research Administration:

The Contractor shall conduct and supervise the study through the Principal Investigator. The Principal Investigator is not an employee of the Contractor, and is not a party to the contract;

however the Contractor will be responsible for obtaining the Principal Investigator’s acknowledgement of the terms and conditions of the contract, and to perform the study in accordance herewith. The Contractor shall maintain organized records and documentation for the administration, budget, and execution requirements of the study.

6. QUALIFICATIONS

7. The Doctoral Student shall possess the following required qualifications for the

AAMTI RIF proposal supported by this contract as described below:

7.1 Shall have the ability to assist the Principal Investigator with creating the deliverables outlined in section 9

7.2 Shall have at least 2 years of experience in the field of vestibular assessment;

7.3 Shall have at least 2 years of experience in the development and application of SARA technology for understanding and addressing significant issues in sensorimotor function following vestibular injury or disease;

7.4 Shall have experience with statistical analyses beyond that of a Bachelor’s degree;

and experience using Microsoft Office and SPSS software.

8. DELIVERABLES

The Contractor shall provide the following deliverables:

8.1 Monthly – A written report of work accomplished, due with fifteen (10 calendar days following the end of the reporting period (calendar month). Written report of work accomplished in support of the U.S. Army Medical Department Center & School, to include:

Update on tasks assigned, in progress, and completed;

Update on any administrative or study related problems/issues; and Update on problems/issues identified in previous reporting period.

8.2 Final Report – A research report describing the content and criterion validity of a virtual reality version of VAN and TAN in approximately 20 individuals with central (mild traumatic brain injury) and/or peripheral vestibular disorders.