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

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