The purpose of this study is to determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. This study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility. * Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase. * Completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed. * Useability: all therapists and subjects must rate useability as good or better. * Success of blind: subject accuracy at guessing group membership must be at or near 50%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
Delivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Recruitment rate
Number and percentage of subjects recruited over the 36 week pilot recruitment phase
Time frame: 36 weeks
Completion and compliance rates
Number and percentage of subjects who complete the study
Time frame: Up to 12 weeks
Usability rating
Number and percentage of subjects and therapists who rated usability as good or better.
Time frame: 12 weeks
Success of blinding
Number and percentage of subjects who accurately guess group membership
Time frame: 12 weeks
Change in Sensory Organization Test (SOT)
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Time frame: 12 weeks
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