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Investigators: S Kalsi-Ryan^1,2, R D’Arcy^3,4,5H Condello⁶, C Chebaro^2,7, J Vaughan-Graham^2,8

‍Affiliations: 1 KITE Research Institute – University Health Network; 2 Department of Physical Therapy and Rehabilitation Sciences Institute, University of Toronto; 3 BrainNET, Applied SciencesSimon FraserUniversity; 4DM Centre for Brain Health, University of British Columbia; 5 Centre for NeurologyStudies, HealthTech Connex; 6 Complex Injury Rehab; 7 Neurocore Physiotherapy; 8 Physio-Logic Rehabilitation Services

‍Background: Although the majority of persons who suffer a mild TBI recover within a period of 10-14 days, recovery timelines are highly variable. An estimated 15-20% of persons affected by a mild TBI experience persisting symptoms affecting their ability to return to school, work and perform independent activities of daily living. Cranial nerve non-invasive neuromodulation (CN-NINM) has been shown to significantly improve balance and gait for those who suffer chronic balance deficits following mild-to-moderate TBI (mmTBI) and whom plateaued on prior conventional therapies.

‍Rationale: Unresolved gait and balance problems are common amongst persons with mmTBI. Understanding the benefits of CN-NINM in the treatment and resolution of balance and gait deficits in persons with mmTBI is essential in developing a clinically relevant evidence base . A clinical feasibility program was undertaken to gain a greater understanding through experience, the application, feasibility and outcome of aPoNS mmTBI program.

‍Methods: A pre-post design was used. All therapists and researchers involved in the delivery of the PoNS mmTBI program participated in an in-person 2day training program to become PoNS certified. Potential participants were referred from the community as well as TBI/concussion programs to the Principal investigator. All potential participants were screened, and, if eligible, were assessed by a neurosurgeon for review and clearance. On medical clearance the participant underwent baseline assessments. The PoNS mmTBI program was delivered via private community neuro-rehabilitation clinics in the greaterToronto area. All baseline and follow-up assessments were conducted by an independent assessor who was not blinded, but was not involved in the delivery of the treatment program. Six participants with mmTBI were recruited and enrolled to the study from January 2020 to February 2021. The PoNS mmTBI program was a 14 week physical therapy program coupled with PoNS stimulation. Outcome assessments were conducted prior to program initiation, at 2 weeks, 8 weeks and 14 weeks after program initiation.The primary outcome measure was the Community Balance and Mobility Scale(CB&M). Secondary outcome measures included the Functional Gait Assessment (FGA) and the NeuroCatch (N100, P300,& N400).

‍Results: Fourteen individuals were screened, 8 were eligible and 8completed baseline assessment. Two participants did not initiate the program; 6commenced the PoNS mmTBI program, 1 dropped out of the program at weeks 2 due to the intensity of the program. Mean (SD) change scores towards improvement for CB&M and FGA were 18 (11.2) and 6.2 (2.7) respectively. Examination of NeuroCatch results showed improvements in the speed of cognitive processing, as measured by the N400, within the group.

‍Conclusions: Individuals with persistent gait and balance deficits related to mmTBI demonstrated significant and clinically meaningful improvements in balance, gait and speed of cognitive processing following a PoNS mmTBI program.