PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI) (NCT03881176) | Clinical Trial Compass
CompletedNot Applicable
PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)
United States20 participantsStarted 2018-09-21
Plain-language summary
\- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device.
Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕. If female, the subject is not pregnant, not breastfeeding and has a negative pregnancy test prior to receipt of the PoNS device
✕
What they're measuring
1
Mean change in balance score (Bertec) from baseline to the end of 14 weeks
Timeframe: Baseline, 2 weeks, 5 weeks and 14 weeks
. If female is of childbearing potential, the subject agrees to use adequate contraception from screening and throughout the study period.
✕. Balance disorder due to a mild-to-moderate traumatic brain injury (TBI), as indicated by the Bertec Balance Advantage - Sensory Organization Test (SOT) composite score at least 16 points below normal \[adjusted for age and height, based on normative data\].
✕. At least three (3) months post most recent TBI at the time of screening.