Clinical Trial: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
Brief Summary:
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%.
Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Recruitment rate [ Time Frame: 36 weeks ]Number and percentage of subjects recruited over the 36 week pilot recruitment phase
- Completion and compliance rates [ Time Frame: Up to 12 weeks ]Number and percentage of subjects who complete the study
- Usability rating [ Time Frame: 12 weeks ]Number and percentage of subjects and therapists who rated usability as good or better.
- Success of blinding [ Time Frame: 12 weeks ]Number and percentage of subjects who accurately guess group membership
- Change in Sensory Organization Test (SOT) [ Time Frame: 12 weeks ]Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: April 7, 2014
Date Started: June 2015
Date Completion: August 2016
Last Updated: May 29, 2015
Last Verified: May 2015