A Prospective, Multicenter Study to Assess the Safety and Efficacy of Translingual Neurostimulation Plus Physical Therapy for the Treatment of a Chronic Balance Deficit Due to Mild-to-Moderate Traumatic Brain Injury

This study investigates the use of translingual neurostimulation (TLNS) combined with physical therapy (PT) to treat chronic balance deficits in people who have experienced mild to moderate traumatic brain injury (mmTBI). TLNS involves stimulating cranial nerves via the tongue. Participants with a chronic balance deficit after mmTBI, who had plateaued in recovery after prior conventional PT, were enrolled in the study. They were randomized to receive PT plus either high-frequency pulse (HFP) or low-frequency pulse (LFP) TLNS. The study found that both HFP and LFP TLNS, when combined with targeted PT, led to significant improvements in balance and gait, as well as reductions in headaches, improved sleep quality and reduced fall frequency. The improvements occurred in participants who had plateaued on prior conventional physiotherapy.

• 1
  The proportion of SOT responders was significant in the HFP + PT (71.2%) and LFP + PT (63.5%) groups compared with baseline (p < 0.0005).
• 2
  For the pooled population, the SOT responder rate was 67.2% (p < 0.00005), and there were clinically and statistically significant improvements in SOT composite scores after two and five weeks (p < 0.0005).
• 3
  Both groups had reductions in falls and headache disability index scores. Mean dynamic gait index scores in both groups also significantly increased from baseline at weeks 2 and 5.