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

Study Overview
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Brief Summary
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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).

Official Title
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Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: Active CN-NINM PoNS
* Device: Sham CN-NINM PoNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran or Servicemember 18 to 50 years old Sustained one or more mild traumatic brain injury (mTBI)s 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)) Available for the duration of the study Exclusion Criteria: History of traumatic brain injury (TBI) of any severity other than mild TBI Presence of active substance abuse condition Any condition for which posturography is contraindicated (e.g. leg amputation or fracture) Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis) Orthostatic hypotension as defined by: A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg A diastolic blood pressure decrease of at least 10 mmHg, or A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion An implanted medical device Pregnancy Oral infection Known transmissible disease (HIV, hepatitis, influenza, TB) Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active PoNS CN-NINM<br>Active CN-NINM PoNS - Active cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy | Device: Active CN-NINM PoNS<br>* 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.<br>* Other names: Portable Neuromodulation Stimulator (PoNS);|
| Sham Comparator: Sham PoNS CN-NINM<br>Sham CN-NINM PoNS - Sham cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy | Device: Sham CN-NINM PoNS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sensory Organization Test (SOT) | Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner. | 12 weeks | 
| Change in neuroimaging using functional magnetic resonance imaging (fMRI) | For fMRI, a repeated single-shot echo-planar imaging will be acquired | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Traumatic Brain Injury