PoNS Clinical Experience Program (TBI)

Exclusion criteria

• . At least 18 years of age, inclusive, at the time of screening.
• . Acceptable results (as determined by the investigator) of a full history and physical performed or supervised by the investigator at each site. This will include a careful examination of the tongue and oral cavity for any abnormalities. History should include the nature and duration of any prior physical therapy program the subject may have participated in to address the balance and/or gait symptoms of their TBI. Prior participation in therapy is not a prerequisite for enrollment in the program
• . Documentation on the history of a qualifying TBI, mild to moderate in severity. For reference, the Armed Forces Health Surveillance Branch (AFHSB) definitions of mild and moderate TBI will be used. The definitions are as follows:
• . Acceptable results from within the last three (3) months as determined by the site investigator of basic standard blood work to include CBC, TSH, HbA1C, Liver and Kidney panels, and a 12-lead ECG with automated reporting capability. Any abnormal result that is judged clinically significant by the investigator will be communicated to the subject and if treated by their personal physician and deemed recovered, the subjects may be reconsidered for inclusion. If the investigator is uncertain he or she will communicate with the Sponsor's Medical Officer.