The TBI-001 trial (NCT01847755) found that translingual neurostimulation with a portable device (PoNS; Helius Medical Technologies, Newtown, PA) provided significant balance improvement in for individuals with chronic balance deficit after mild-to-moderate traumatic brain injury (mmTBI). These results have been published in the Archives of Rehabilitation Research and Clinical Translation.
Individuals with chronic balance impairment after mmTBI that occurred at least 1 year prior who were no longer improving with physical therapy alone were treated with translingual stimulation and physical therapy. Of those treated, 67.2% had a statistically significant improvement in balance as measured by mean Sensory Organizational Test (SOT) scores at 2 and 5 weeks compared with baseline. Mean Dynamic Gait Index (DGI) scores were also significantly increased from baseline at weeks 2 and 5.
“Whether traumatic brain injuries are mild, moderate or severe, the devastating effects can last a lifetime,” said Philippe Deschamps, chief executive officer of Helius Medical Technologies. “We are excited to announce the publication of (the results of TBI-001) and believe that it provides important clinical support for the PoNS treatment as new, novel, valuable treatment option for patients suffering from the effects of mmTBI. As a result of their improvements in balance and gait, many of our patients reported being able to perform independent self-care tasks, like dressing and showering, that were once beyond their reach prior to receiving PoNS treatment.”
Katherine Webb, a participant in the study described her experience during the study. “It had been 4 and a half years since my injury when I first started the study. For those 4 and a half years, I had not been able to put one foot in tandem in front of the other and walk with my feet in a row without tipping or falling over due to loss of balance. It was early February of 2017, and with the device in my mouth, I walked the line. The Physiotherapist FaceTimed my husband and daughter who were flooded with tears as they watched. As a result of my improved balance throughout the study I experienced many more firsts since my TBI, like washing my hair without having to balance against the shower walls for stability,” said Katherine Webb.
Peter McAllister, MD
Farhat Husain, MD; Divya Singhal, MD; and Sergio Ramirez Salazar, MD
Rachana Gandhi Mehta, MD; Vanessa Baute Penry, MD; and Herbert Lloyd Bonkovsky, MD