Assistant Professor Medical University of South Carolin - - Charleston, SC North Charleston, South Carolina, United States
Background: Transcutaneous auricular Vagus Nerve Stimulation (taVNS) may boost rehabilitation outcomes when paired with motor activities, producing greater functional gains with intensive therapies. It is critical to assure fidelity to the principles of high quality rehabilitation interventions when combining taVNS with intensive therapy. Objective: To determine if therapists can deliver high fidelity CIMT while using self-triggering taVNS. Design/Methods: Prospective, open label, pilot trial for 3 infants, 6-18 months of age, with hemiparesis who received 40hours of CIMT combined with taVNS (NCT05101707). Therapists provided signature CIMT approach during video- recorded sessions. Videos were reviewed by 2 separate reviewers and scored using the Fidelity of Implementation Measure (FIRM). Motor improvements were quantified via the QUEST (grasp) and GMFM (gross motor function) before, immediately after, and 3mo after the 40h CIMT+taVNS treatment. Results: 24 videos of 3 infants reviewed resulted in an average FIRM score range of 3.54-3.73; indicating therapists adhered to intervention components with only minor exceptions that did not compromise CIMT protocol. Children tolerated the taVNS stimulation during CIMT without any adverse events. Therapists were easily able to use the handheld trigger during CIMT sessions. We delivered CIMT for 114 8min per session delivering stimulation at a mean intensity of 0.57mA. All 3 infants showed significant gains in motor assessments relative to their baseline. All 3 infants showed grasp gains on the QUEST: (MCID: Δ 4.89) Infant 1 (Δ=29.56), Infant 2 (Δ=7.41), and Infant 3 (Δ=20.55); and gross motor gains on the GMFM-88, (MCID Δ 5-7), Infant 1 (Δ=4); infant 2 (Δ=23) and infant 3 (Δ=13).
Conclusion(s): CIMT combined with non-invasive taVNS can be delivered with consistent fidelity to treatment protocols. taVNS-paired with CIMT appears safe and feasible. Combining taVNS with intensive CIMT may boost neuroplasticity, allowing for delivery of infant therapy at a minimally effective dosage (40h) while improving infant outcomes.
