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.
Marwa Kaisey, MD, and Nancy L. Sicotte MD, FAAN
Melissa W. Ko, MD; Kevin E. Lai, MD; and Devin D. Mackay, MD
Audrius V. Plioplys, MD