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Treatment of Vestibular Impairment of Service Members after Traumatic Brain Injury through Use of an Individualized, Portable Neuromodulation Device

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: To develop a wearable portable stimulator to stimulate the vestibular system and produce immediate improvements in dizziness, balance, gait and overall vestibular function. To enable Service Members to return to duty after suffering injuries that result in vestibular dysfunction. 

DESCRIPTION: Mild traumatic brain injury (mTBI) has been called the “signature injury” of the recent conflicts in Iraq and Afghanistan.1-2 Documentation of vestibular symptoms following these injuries is common, with over 50% of soldiers reporting dizziness post injury and an additional 5-6% complaining of dizziness post-deployment.3 Vestibular damage is not only related to symptoms of dizziness and vertigo but also visual disturbance and imbalance contributing to increased fall risk. Veterans from a wide variety of backgrounds and multiple eras are faced with vestibular impairment and its associated consequences. A recent study of 13,746 OEF/OIF veterans found a 22.4% incidence of vestibular impairment and vestibular dysfunction has been demonstrated in 25% of veterans from the first Gulf War, with commonly reported symptoms including nausea (52%) and dizziness (17%). Correction of dizziness and balance issues remains largely unsolvable from the pharmacy counter. Vestibular rehabilitation, a specialized form of therapy, is the primary treatment strategy to improve symptoms of dizziness related to mTBI/concussion and other pathologies of the inner ear. Limitations with access to skilled rehabilitation providers - both on and off the battlefield - delays treatment, prolongs symptoms and negatively affects an individual’s readiness for duty. Recent research has demonstrated a minimal amount of electrical vestibular stimulation with stochastic resonance can improve stability in patients with vestibular hypofunction.4 Researchers have also shown that a weak electric “noise” can improve balance and motor skills in patients with Parkinson’s disease.5 Building on these research advances, a portable device which can be worn to stimulate the vestibular system using stochastic resonance could significantly enhance the capability to effectively and expeditiously provide relief from vestibular decrements and therefore represents a significant deployment related health solution. Such a solution would directly address a current force capability gap in the ability to proficiently treat and rehabilitate vestibular injury and balance dysfunction. The objective of this topic is to support development of a portable stimulator, about the size of a hearing aid, which can be worn by the end user to deliver a type of vestibular stimulation resulting in relief. A portable stimulator to enhance vestibular function would improve physical function and enable individuals to seamlessly continue duty tasks. If proven effective over a longer term, this device could be made available to veterans or civilians with chronic balance problems, an area where there are currently limited treatments.  

PHASE I: Phase I projects for this topic will conceptualize the technology and identify design specifications. The proposed device should be portable and non-invasive, similar to a hearing aid, and be able to deliver subsensory electrical noise. Studies have shown stability improvements from stochastic resonance using vestibular electrical stimulation when the frequency of stimulation is restricted to a narrow band, less than 5 Hz, while amplitudes of stimulation have ranged from the microampere range to the 1.5-mA range4. Therefore, levels of electrical noise should be low (<2 Hz noise signal), well below a consciously detectable perception, and should be capable of delivering a constant bipolar stimulus in the mA range with minimal user interaction. By the end of Phase I, technical parameters should be solidified and operational functionality established. Clinical experts with insight into relevant patient populations should be consulted during the initial design phase for future clinical studies. 

PHASE II: Based on Phase I design parameters, Phase II work will demonstrate, optimize and validate what constitutes a functional prototype. Phase II projects will demonstrate the ability of the non-invasive, portable device to improve functional capacity (e.g., balance, relieve dizziness) in a population shown to have vestibular impairment. Data obtained in Phase II will provide proof-of-concept that the device will provide abatement of vestibular impairment and improve physical function. Confirmation of no awareness of stimulus should be demonstrated during clinical testing to ensure input noise is at a sub-perceptual threshold. Parameters including device class, general controls, substantial equivalence, and premarket approval will be defined. Clinical experts with insight into relevant patient populations should be consulted as the system is being fully optimized. Potential commercial and clinical partners for Phase III and beyond should be identified. Phase II technical proposals should include a plan for commercial production of the prototype, including potential manufacturing partnerships and funding strategy. The FDA regulatory plan and an outline for approval are deliverables from Phase II. 

PHASE III: Phase III will focus on work that derives from, extends, or logically concludes efforts performed under SBIR agreements. A description of how the technology and device will transition from research to operational capacity should be provided. A proposed DoD customer, such as health care providers at RoC 2 and 3 responding to mTBI in active duty Service Members, and regulatory requirements for these end users should be provided. During Phase III, additional experiments funded by sources other than the SBIR Program will be performed as necessary to ensure FDA IDE approval. A protocol of stimulation parameters that aligns to the Phase II requirements and demonstrates the medical efficacy and feasibility, should be finalized and made commercially viable. A plan for protection of intellectual property should be created and executed. A detailed market analysis will be conducted, an initial application will be submitted for the technology chosen, and a Phase I clinical trial will be initiated. Military application: The effort is relevant to military research efforts in mTBI/concussion. Commercial application: There are currently limited treatments for patients suffering with vestibular loss. This stimulator could easily be translated into a wearable device for other patient populations suffering with vestibular loss and balance impairments. 

REFERENCES: 

1: Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008

2: 358:453‐463.

3:  Schwab KA, Ivins B, Cramer G, Johnson W, Sluss‐Tiller M, Kiley K, et al. Screening for traumatic brain injury in troops returning from deployment in afghanistan and iraq: Initial investigation of the usefulness of a short screening tool for traumatic brain injury. The Journal of head trauma rehabilitation. 2007

4: 22:377‐389.

5:  Terrio H, Brenner LA, Ivins BJ, Cho JM, Helmick K, Schwab K, Scally K, Bretthauer R, Warden D. Traumatic brain injury screening: preliminary findings in a US Army Brigade Combat Team. J Head Trauma Rehabil. 2009 Jan-Feb

6:  24(1):14-23.

7:  Mulavara AP, Fiedler MJ, Kofman IS, Wood SJ, Serrador JM, Peters B, Cohen HS, Reschke MF, Bloomberg JJ. Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics. Exp Brain Res. 2011 Apr

8: 210(2):303-12.

9:  Khoshnam M, Häner DMC, Kuatsjah E, Zhang X, Menon C. Effects of Galvanic Vestibular Stimulation on Upper and Lower Extremities Motor Symptoms in Parkinson's Disease. Front Neurosci. 2018 Sep 11

10: 12:633. doi: 10.3389/fnins.2018.00633. PMID:30254564.

KEYWORDS: MTBI, Concussion, Vestibular Function, Inner Ear, Portable Stimulator, Balance 

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