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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
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.
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Change in Sensory Organization Test (SOT)
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Time frame: 12 weeks
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)
DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
Time frame: 12 weeks
Change in neuroimaging using functional magnetic resonance imaging (fMRI)
For fMRI, a repeated single-shot echo-planar imaging will be acquired
Time frame: 12 weeks
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