Paired Vagus Nerve Stimulation for Chronic Stroke: Preliminary Findings of Real-world Feasibility in the Home Environment

Research Objectives: To investigate feasibility and acceptance of Vivistim™ Paired Vagus Nerve Stimulation (Paired VNS) for upper extremity (UE) rehabilitation delivered exclusively in the home setting.

Design: Single arm case series

Setting: Homecare

Participants: Six chronic stroke survivors (4 males; 59.6 ± 13.0 years; 1-17 years since stroke) implanted with a VNS device (Vivistim). Participants were enrolled from 5 different sites. The average baseline Fugl-Meyer Assessment-Upper Extremity (FMA) score was 26.8 (±7.7).

Interventions: VNS paired with high intensity and task-specific UE rehabilitation delivered exclusively in the home environment by a therapist. Participants were expected to receive 36 hours of UE paired VNS within 18 weeks. Additionally, subjects were instructed to self-activate VNS via a magnet swipe before starting a home program or daily activities.

Main Outcome Measures: Percent of participants who received at least 24 hours of in home Paired VNS delivered by a therapist. Other endpoints included changes in the FMA, Action Research Arm Test (ARAT), Box and Block Test (BBT), Stroke Impact Scale (SIS) and Motor Activity Log-14 (MAL). Assessments were done at baseline and after completion of 12, 24 and 36 hours of supervised Paired VNS sessions.

Results: 100% of participants completed at least 24 hours of sessions delivered at home. On average, participants completed 36.1 (±3.6) hours of supervised therapy over 12.9 (±3.8) weeks, with sessions lasting 83.5 (±6.7) minutes. The mean changes after 36 hours of supervised sessions were: FMA: 8.3 (±7.1), ARAT: 4.5 (±4.1), BBT: 3.3 (±6.5), SIS-Hand: 18.3 (±12.1); MAL: 0.4 (±0.9).

Conclusions: The benefits of Paired VNS were initially established in-clinic; however, challenges such as time, mobility, or geographic constraints may make this effective therapy less available to many stroke survivors. Our preliminary findings suggest that Paired VNS completed exclusively in the home is feasible and likely has post-stroke recovery benefits, with the potential of reaching more survivors than in-clinic due to its convenient therapy delivery paradigm.

Author(s) Disclosures: LG, SZ: research support from MicroTransponder, Inc.
SZ, RP: consultants for MicroTransponder, Inc.
BT, CNP, NE: employees for MicroTransponder, Inc. in which they hold stock or stock options.