Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators hypothesis is that electrical stimulation to the tongue that directly
      stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural
      impulses to the brainstem and cerebellum. The investigators call this cranial nerve
      non-invasive neuromodulation (CN-NINM). The activation of these structures induces
      neuroplasticity when combined with specific physical, cognitive and/or mental exercises,
      promoting recovery of selected functional damage such as problems with balance or walking.

      44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training
      followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of
      the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use
      very low level stimulation in conjunction with the exercise, and will serve as a control
      group.
    

Detailed description: 
      -  Based on the results of the investigators pilot study in moderate traumatic brain injury
           (M-TBI), the investigators will conduct a randomized, controlled study of cranial nerve
           non-invasive neuromodulation (CN-NINM) in individuals with chronic symptoms of mild to
           moderate traumatic brain injury (mTBI), post-concussive sequelae, (PCS) and
           post-traumatic stress (PTS).

        -  The study will involve training of both balance and gait, with assessments using
           standardized and relevant metrics to monitor changes in these indications, as well as
           cognitive function, sleep, headache, anxiety, mood, and eye-movement control.

        -  The training regimen involves using a neurostimulation intervention that addresses
           primary and secondary symptoms associated with mTBI, PCS, and PTS.

        -  This randomized double blind controlled study will enroll a total of 44 subjects (M & F)
           in 2 equal subgroups: 22 with an Active PoNS™, and 22 with a Control (non-zero,
           minimally perceivable stimulation) device.

        -  Subjects will participate in a 3-phase intervention beginning with a 2-week in-lab
           training program (ITP) (2 in-lab training sessions and 1 home training session daily),
           followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a
           12-week withdrawal period (no training). Subjects will return to the clinic weekly
           during the at-home phase for a single session of retraining and progression, and
           participate in periodic retesting.

        -  All training and testing will be performed uniformly across all subjects in both groups.
           Multiple assessment metrics will capture data at the beginning and end of the 2-week
           in-lab CN-NINM intervention period and at 3-week intervals. After completion of the
           formal training period, subjects will stop using the device (withdrawal stage) and will
           be tested every 3 weeks over an additional 12 weeks to monitor and assess changes due to
           withdrawal of the PoNS. This will yield a total of 10 data points for each subject.

        -  If successful, this study would indicate that CN-NINM may improve rehabilitation
           outcomes and reduce time required to improve function.
    

Intervention name(s): Balance and Gait Training using neurostimulation modulation.; Sham Device
Intervention type(s): Device; Device
Intervention description(s): CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.; The sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation.
Other intervention name(s): Cranial Nerve Non-invasive Neuromodulation (CN-NINM); Portable Neuromodulation Stimulator (PoNS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cranial Nerve Noninvasive Neuromodulation; Portable Neuromodulation Stimulator (PoNS); Balance and Gait Training; Breathing Awareness Training