Clinical Trial: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full 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Study Status: Withdrawn
Recruit Status: Withdrawn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: A Randomized, Double-Blinded, Sham-Controlled, Prospective Tri

Brief Summary: The purpose of this study is to evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).

Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome: 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:

  • Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 12 weeks ]
  • Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI) [ Time Frame: 12 weeks ]
  • Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ) [ Time Frame: 12 weeks ]
  • Change in quality of life measured using Short Form 36 (SF-36) [ Time Frame: 12 weeks ]
  • Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C) [ Time Frame: 12 weeks ]
  • Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI) [ Time Frame: 12 weeks ]
    DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
  • Change in neuroimaging using functional magnetic resonance imaging (fMRI) [ Time Frame: 12 weeks ]
    For fMRI, a repeated single-shot echo-planar imaging will be acquired


Original Secondary Outcome: Same as current

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: April 7, 2014
Date Started: August 2015
Date Completion: December 2016
Last Updated: May 21, 2015
Last Verified: October 2014