Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)

Inclusion criteria

• Male or female, 18-65 years of age
• Documentation on initial TBI (defined as closed-head, non-penetrating, blunt, whiplash, or explosive blast-induced brain injury) severity (at time of injury): Glasgow Coma Scale (GCS) score 9-15, with loss of consciousness < 24 hours, post-traumatic amnesia ≤7 days, or hospital admission ≤ 7 days post TBI
• If female, subject is not pregnant, not lactating, has a negative pregnancy test prior to receipt of the PoNS™ device, and agrees to use contraception from screening to end of the study
• Balance disorder with SOT composite score at least 16 points below normal resulting from a mild/moderate TBI without any concomitant pathologies
• At least 1 year post injury
• Stable neurologic status
• Prior participation in a focused physical rehabilitation program for TBI and deemed by their treating clinician/themselves to have reached a plateau
• Able to walk continuously on a treadmill for 20 minutes, level grade and at any speed, with support if needed
• Access to a treadmill and commitment to utilize this for the at-home portion of the study
• Able to understand the study procedures and give informed consent
• Willing and able to adhere to the study schedule
• Willing to complete a neuropsychological evaluation prior to inclusion

Exclusion criteria

• Medical finding from screening history and physical examination that is clinically significant or would otherwise impact patient safety or data integrity
• Medical finding from prior neuroradiologic study or recent MRI that is significant or that would impact patient safety or data integrity
• Planned use or use of any investigational product, pharmaceutical or device within 30 days preceding receipt of the PoNS device and during the entire study
• Balance or gait deficits due to lower extremity injury or neurological condition other than TBI
• Penetrating brain injury, craniotomy or refractory subdural hematoma
• Oral health problems at the time of recruitment
• Oral surgery within 3 months of screening
• History of oral cancer
• Non-removable metal orthodontic devices that could interfere with PoNS use
• Presence of metallic implant or other MRI-incompatible device
• Blood pressure abnormalities considered clinically significant
• Use of Coumadin or other anticoagulant except aspirin in the last 6 months
• Untreated or undiagnosed diabetes
• Diabetic neuropathy
• Active or recent (within 1 year) treatment for any cancer, excluding basal cell carcinoma.
• Neurological disorders other than those attributed to the primary diagnosis (neurodegenerative diseases such as Multiple Sclerosis, Parkinson's disease, Alzheimer's disease or other dementia, Amyotrophic Lateral Sclerosis)
• History of epileptic or other seizure disorders
• Known ischemic heart disease and/or history or atrial or ventricular arrhythmias with or without syncope
• Any other untreated or unstable acute or chronic, clinically significant medical condition for which the subject is currently undergoing treatment that the study investigator deems unsuitable for inclusion
• Use of a lower extremity biomechanical prosthetic with the exception of a splint for foot drop
• Females who are pregnant, lactating, or planning to become pregnant during the study
• Chronic use of any potentially interfering medication, or use of any medication that would compromise the ability to function or perform the study activities
• Addition of and/or major change in type or dosage of any prescription medication within 3 months prior to receipt of the PoNS device
• Active alcoholism. The study investigator will have the right to exclude subject participation if the subject seems intoxicated at time of screening and/or during any study appointment.
• History of drug abuse will be assessed
• Recent history of smokeless tobacco use
• Any reason that may be a threat to health or safety
• Any finding in the neuropsychological evaluation that makes the subject unsuitable for inclusion