Mild Traumatic Brain Injury
Conditions
Keywords
Mild Traumatic Brain Injury
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).
Interventions
DEVICEActive 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.
DEVICESham 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.
Sponsors
Virginia Commonwealth University
US Department of Veterans Affairs
The Defense and Veterans Brain Injury Center
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Veteran or Servicemember 2. 18 to 50 years old 3. Sustained one or more mild traumatic brain injury (mTBI)s 4. Demonstration of balance deficits on the Sensory Organization Test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample)) 5. Available for the duration of the study
Exclusion criteria
1. History of traumatic brain injury (TBI) of any severity other than mild TBI 2. Presence of active substance abuse condition 3. Any condition for which posturography is contraindicated (e.g. leg amputation or fracture) 4. Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis) 5. Orthostatic hypotension as defined by: 1. A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg 2. A diastolic blood pressure decrease of at least 10 mmHg, or 3. A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion 6. An implanted medical device 7. Pregnancy 8. Oral infection 9. Known transmissible disease (HIV, hepatitis, influenza, TB) 10. Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensory Organization Test (SOT) | 12 weeks | Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI) | 12 weeks | — |
| Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI) | 12 weeks | — |
| Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ) | 12 weeks | — |
| Change in quality of life measured using Short Form 36 (SF-36) | 12 weeks | — |
| Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C) | 12 weeks | — |
| Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI) | 12 weeks | DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner. |
| Change in neuroimaging using functional magnetic resonance imaging (fMRI) | 12 weeks | For fMRI, a repeated single-shot echo-planar imaging will be acquired |
Countries
United States
Outcome results
None listed