At a glance
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Cranial Nerve Noninvasive Neuromodulation Using the PoNS for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury
In Brief
A clinical study evaluating Balance and Gait Training using neurostimulation modulation. and Sham Device for Brain Injuries, Traumatic. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.