Disclosures: Gerard E. Francisco, MD: Microtransponder (Products/Services: Yes) (Research Grant or Support)
Objective: To report long-term safety and outcome data from a randomized double-blind study of Vagus Nerve Stimulation (VNS) paired with home-based rehabilitation program in persons with chronic ischemic stroke.
Design: Long-term follow-up from randomized double-blind study Setting : Home-based Rehabilitation Participants : We enrolled 17 participants at 4 centers. All were implanted with VNS device. Post-implantation, they were randomized to VNS combined with rehabilitation (Active VNS; n=8) or rehabilitation alone (Control; n=9). After six weeks of in-clinic therapy and 3 months of home-based therapy, controls crossed over to receive Active VNS. Both groups continued to receive Active VNS long-term.
Interventions: Participants executed a daily 30 min home exercise program paired with VNS during which the participants self-administered VNS via a single magnet swipe at the start of each session. The magnet swipe triggered VNS every 10 seconds for 30 minutes. Home program consisted of individualized task-based, challenging exercises designed by a physical therapist.
Main Outcome Measures: Upper Extremity Fugl-Meyer Assessment (FMA-UE) and Wolf Motor Function Test (WMFT) were assessed 6 months through 3 years post-therapy. Long-term outcome data were pooled from both groups receiving Active VNS therapy.
Results: Data were available for 14/17 participants. No VNS treatment–related serious adverse events were reported. Pooled FMA-UE improved by 14.7 points from baseline at 3 years (CI = 8.9 to 20.6, p < .0001) and 80% of participants demonstrated clinically meaningful response (≥ 6-point change in FMA-UE). WMFT improved by 0.76 points (CI = 0.35 to 1.15, p = .001). WMFT-time improved by 7.9 seconds (CI = 1.7 to 14, p = .01). Conclusions: Long-term high-intensity home-based rehabilitation paired with VNS may improve upper extremity motor function in participants with moderate-to-severe arm weakness resulting from chronic, ischemic stroke.
Level of Evidence: Level I
To cite this abstract in AMA style:
Francisco GE. Vagus Nerve Stimulation Paired with Upper Limb Rehabilitation After Stroke: Long-term Outcomes [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/vagus-nerve-stimulation-paired-with-upper-limb-rehabilitation-after-stroke-long-term-outcomes/. Accessed May 9, 2025.« Back to AAPM&R Annual Assembly 2020
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/vagus-nerve-stimulation-paired-with-upper-limb-rehabilitation-after-stroke-long-term-outcomes/