Disclosures: Kim Skinner, PT, DPT: Helius Medical, Inc: Employment, Stockholder/Ownership Interest (excluding diversified mutual funds)

Objective: To determine whether the PoNS™ plus targeted physical therapy (PT; PoNS™ Treatment) at a high-frequency pulse (HFP) is more efficacious than a low-frequency pulse (LFP) in participants with mild-to-moderate traumatic brain injury (mmTBI).

Design: This double-blind study (NCT02158494) consisted of 14 weeks of PoNS™ Treatment, then 12 weeks of normal activity without PoNS™ Treatment. In a structural magnetic resonance imaging sub-study (n = 9), scans were performed at baseline and after 2 weeks of treatment to assess changes in gray matter volume (GMV) and cortical thickness.

Setting: This study was conducted at an academic laboratory with in-clinic/at-home sessions.

Participants: Adults with a balance disorder from mmTBI ≥1 year prior to enrollment and a NeuroCom Sensory Organization Test (SOT) composite score ≥16 points below normal were eligible. All participants had plateaued following PT.

Interventions: PoNS™ Treatment is noninvasive stimulation of the brain via the cranial nerves innervating the tongue. Participants were randomized into HFP and LFP treatment groups.

Main Outcome Measures: The primary endpoint was the change in SOT composite score from baseline to week 14.

Results: 43 participants were treated (22 HFP, 21 LFP). The difference in SOT composite score between treatment groups was not significant at weeks 2, 14, or 26. Post-hoc analysis of the combined treatment groups demonstrated statistically significant (P<.0005) and clinically meaningful improvements in the SOT composite score from baseline to weeks 2, 14, and 26. Brain regions involved in balance-control and multisensory integration had the largest GMV increase post-treatment and correlated with changes in functional assessments at 2 weeks.

Conclusions: The combination of PoNS™ and targeted PT produced significant improvements in the SOT composite score, which were sustained for at least 12 weeks after intervention was discontinued. GMV increased in balance-controlling and multi-sensory integrating brain regions post-treatment. Overall, PoNS™ Treatment appears safe and effective at promoting neuromodulation to improve persistent balance deficit in patients with mmTBI.

Level of Evidence: Level I

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/neurorehabilitation-using-the-portable-neuromodulation-stimulator-pons-for-treating-participants-with-chronic-balance-deficit-due-to-mild-to-moderate-traumatic-brain-injury-a-26-week-study/