The patients enrolled in the clinical trials had to have suffered from a mild-to-moderate traumatic brain injury (mmTBI, including concussion or post-concussive syndrome) within the last year of the start of the study. They were still experiencing chronic balance deficit which is demonstrated as symptoms such as dizziness, difficulty walking, trouble climbing stairs, and/or difficulty completing everyday tasks. They were between the ages of 18-65 years old and were fit enough to walk unassisted for 20 minutes or more.
Kim Skinner, PT, DPT
Director of Physical Therapy, Helius Medical Technologies
“As the lead physiotherapist involved in the clinical trials, I saw firsthand some of the most impactful and meaningful changes that participants experienced. As a result of improvements in their balance and gait, they were able to perform independent self-care tasks such as dressing, showering, walking up and down the driveway, and going grocery shopping.”
In patients with chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI, including concussion or post-concussive syndrome), PoNS™ was studied in conjunction with targeted physical therapy in 2 clinical trials involving 165 patients1,2
|5-week Miltisite Study|
|26-weeks Single-site Study|
Inclusion & Exclusion Criteria
(for both TBI-001 & Long-Term Treatment Trial)
Both trials had a high-frequency pulse (HFP) and low-frequency pulse (LFP) stimulation arm, in conjunction with physiotherapy.2,3
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1. Helius Medical Technologies. Data on File. 2019 Post Hoc Analysis – Long Term Treatment Trial – Responder rate – Pharma Data Associates
2. Tyler M, et al. Arch Res Rehabil Clin Transl. 2019; 1(3-4):10026.