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Study Status: Withdrawn
Recruit Status: Withdrawn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