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

Study Overview
=================
Brief 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%.

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

Conditions
-----------------
Mild Traumatic Brain Injury

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active CN-NINM PoNS<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);|
| Placebo 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number and percentage of subjects recruited over the 36 week pilot recruitment phase | 36 weeks | 
| Completion and compliance rates | Number and percentage of subjects who complete the study | Up to 12 weeks | 
| Usability rating | Number and percentage of subjects and therapists who rated usability as good or better. | 12 weeks | 
| Success of blinding | Number and percentage of subjects who accurately guess group membership | 12 weeks | 
| 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 | 

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