NCT02109198

Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)

Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Active CN-NINM PoNS	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.
DEVICE	Sham CN-NINM PoNS	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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-04-09
• Last updated: 2015-06-02

Locations

2 sites across 1 country: United States