PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)

Criteria for Inclusion/Exclusion:

Subjects must present with a chronic balance deficit due to mild-to-moderate TBI. However, other potentially related symptoms, such as gait disturbance, mild to moderate recurrent headaches, sleep, memory, attention, and cognitive deficits, will be noted on the data collection form at screening and each subsequent evaluation.

Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study:

1. At least 18 years of age, inclusive, at the time of screening.

2. Acceptable results (as determined by the investigator) of a full history andphysical performed or supervised by the investigator at each site. This will includea careful examination of the tongue and oral cavity for any abnormalities. Historyshould include the nature and duration of any prior physical therapy program thesubject may have participated in to address the balance and/or gait symptoms oftheir TBI. Prior participation in therapy is not a prerequisite for enrollment inthe program

3. Documentation on the history of a qualifying TBI, mild to moderate in severity. Forreference, the Armed Forces Health Surveillance Branch (AFHSB) definitions of mildand moderate TBI will be used. The definitions are as follows:

• Mild TBI: Confused or disoriented state which lasts less than 24 hours; or lossof consciousness for up to 30 minutes, or memory loss lasting less than 24hours. Excludes penetrating TBI.

• Moderate TBI: Confused or disoriented state which lasts more than 24 hours;and/or loss of consciousness for more than 30 minutes but less than 24 hours,or memory loss lasting greater than 24 hours but less than seven days; or meetscriteria for Mild TBI except an abnormal CT scan is present. Excludespenetrating TBI. The investigator will ascertain whether the prior medical records and informationcollected during the clinical interview are sufficiently detailed to support theclassification of the TBI.

4. Acceptable results from within the last three (3) months as determined by the siteinvestigator of basic standard blood work to include CBC, TSH, HbA1C, Liver andKidney panels, and a 12-lead ECG with automated reporting capability. Any abnormalresult that is judged clinically significant by the investigator will becommunicated to the subject and if treated by their personal physician and deemedrecovered, the subjects may be reconsidered for inclusion. If the investigator isuncertain he or she will communicate with the Sponsor's Medical Officer.

5. If female, the subject is not pregnant, not breastfeeding and has a negativepregnancy test prior to receipt of the PoNS device

• Note: Pregnancy testing will be repeated at end-of-study (EOS) (i.e., end ofat-home period).

6. If female is of childbearing potential, the subject agrees to use adequatecontraception from screening and throughout the study period. A female of non-childbearing potential is defined as a subject who is postmenopausal (continuous amenorrhea for 12 months) or surgically sterile (defined as bilateraltubal ligation, bilateral oophorectomy, or hysterectomy).

7. Balance disorder due to a mild-to-moderate traumatic brain injury (TBI), asindicated by the Bertec Balance Advantage - Sensory Organization Test (SOT)composite score at least 16 points below normal [adjusted for age and height, basedon normative data].

8. At least three (3) months post most recent TBI at the time of screening.

9. Stable neurologic status, as determined from subject's medical records and the studyphysician's opinion based on no new or changing symptoms. The most recentneuroradiologic reports will be entered into the data collection form. For allsubjects who did not have an MRI in association with their most recent TBI, or ifthat MRI showed significant intracranial blood, a new MRI will be obtained with thin (1 mm) cuts to rule out any incidental findings prior to inclusion and theinvestigator may exclude subjects based on any concerns about health or safety.

10. Ambulatory and able to walk continuously over-ground or on a treadmill for 20minutes, level grade (no inclination) and at any speed, with support, if needed.

11. Able to understand the study procedures and give informed consent.

12. Willing and able to adhere to the study schedule.

13. Willing to complete a neuropsychological evaluation if deemed necessary by theinvestigator prior to inclusion in the study.

Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study:

1. Medical findings from screening history, physical examination or radiological testthat the investigator deems clinically significant or that would otherwise impactpatient safety or data integrity.

2. Planned use or use of any investigational product (i.e., not approved by the FDA),pharmaceutical or device, within 30 days preceding receipt of the PoNS device andduring the entire period of subject participation.

3. Any previous use of the Portable Neuromodulation Stimulator (PoNS)

4. Balance or gait deficits due to lower extremity injury or neurological conditionother than TBI.

5. Severe TBI defined as an injury with a confused or disoriented state which lastsmore than 24 hours; and/or loss of consciousness for more than 24 hours, or memoryloss for more than seven days.

6. Penetrating brain injury, refractory subdural hematoma, or craniotomy unrelated tothe resolution of qualifying traumatic brain injury. Investigator discretion may beexercised on an individual case where surgery was performed that did not remove orsignificantly alter brain tissue (e.g., to treat a brain aneurysm). Surgery musthave been performed at least 6 months prior to screening and a CT scan must beprovided to demonstrate no large residual lesions.

7. Oral health problems active at the time of recruitment. Any history of oral healthproblems (e.g., gum disease or cankers) will be noted on the data collection form.

8. Oral surgery within 3 months of screening.

9. History of oral cancer.

10. Non-removable metal orthodontic devices (e.g., braces) or oral cavity piercings thatcould interfere with PoNS use.

11. Presence of metallic implant or other MRI-incompatible device.

12. Known allergy to gold, nickel or copper.

13. Blood pressure abnormalities considered clinically significant by the studyphysician. If the subject has a systolic blood pressure of <100 mmHg, they will beevaluated for orthostatic hypotension and if the investigator deems this a risk forthe subject's health or safety they will be excluded. If systolic blood pressure >160 mm Hg (average of 3 measurements) at screening and the subject is onmedications, the subject will be re-evaluated once the treating physician deems themto have stable blood pressure.

• Note: BP should be measured seated, legs uncrossed, after resting for 5minutes, with measurements taken 2 minutes apart. If the first two readingsdiffer by >5 mm Hg, additional measurements should be taken and averaged.

14. Use of Coumadin or any other anticoagulant other than aspirin in the last sixmonths.

15. Untreated or undiagnosed diabetes or diabetic neuropathy that may interfere withability to participate in the training program.

16. Active or recent (within 1 year) treatment for any cancer, excluding basal cellcarcinoma.

17. Neurological disorders other than those attributed to the primary diagnosis, (e.g.,neurodegenerative diseases such as Multiple Sclerosis (MS), Parkinson's disease (PD), Alzheimer's disease (AD) or other dementia, Amyotrophic Lateral Sclerosis (ALS).

18. History of epileptic or other seizure disorders.

19. Known ischemic heart disease (angina, stent, history of myocardial infarction, >70%stenosis or cardiovascular imaging) and/or history or atrial or ventriculararrhythmias with or without syncope. Any abnormality on the screening ECG will bereferred to the subject's family physician for evaluation and clearance and then thesubject can be re-evaluated for inclusion in the study.

20. Any other untreated or unstable acute or chronic, clinically significant medicalcondition for which the subject is currently undergoing treatment (e.g., autoimmuneor immunodeficient disorders) and that the investigator deems unsuitable forinclusion.

21. Use of a lower extremity biomechanical prosthetic with the exception of a splint toaddress foot drop.

22. Chronic use of any potentially interfering drug such as a neuroactive (ototoxic,anti-seizure, anti-convulsive) medication, or chronic/PRN use of any medication thatwould, in the opinion of the investigator, compromise the subject's ability tofunction or perform the study activities.

23. Addition of and/or major change in type or dosage of any prescription medicationwithin 3 months prior to receipt of the PoNS device at the time of screening,subject to physician discretion.

24. Active alcoholism documented by the investigator at the time of screening. Theinvestigator will have the right to exclude subject participation if, in theiropinion, the subject seems intoxicated at time of screening and/or during any studyappointment.

25. History of drug abuse as documented by the investigator at the time of screening.The investigator will have the right to exclude subject participation if, in theiropinion, the subject seems intoxicated at time of screening or presentation fortreatment

26. Recent (6 months) history of smokeless tobacco use (i.e., chewing tobacco, oraltobacco, spit or spitting tobacco, dip, chew, snuff*) (*NCI definition)

• Note: Cigarette, cigar, pipe, and/or e-cigarette use is not exclusionary

27. Any reason, considered by the principal investigator or designee to preclude subjectenrollment in the study that might represent a threat to health, safety, or aninability to comply with the study protocol.

28. Subject is incompatible with the device.

29. Subject is currently in a focused physical rehabilitation program for balance orgait symptoms resulting from their TBI and has not been deemed by their treatingclinician to have reached a plateau.