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

Mild Traumatic Brain Injury Clinical Trial

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

Clinical Trial 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%.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02109198
Study type Interventional
Source U.S. Army Medical Research and Materiel Command
Contact
Status Withdrawn
Phase N/A
Start date June 2015
Completion date August 2016
View Details
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