Study protocol for the Vivistim GRASP registry: capturing real-world outcomes of paired vagus nerve stimulation in the chronic stroke population.

Abstract

Objective: To capture real-world use and outcomes from chronic stroke survivors with arm and hand impairment implanted with a paired vagus nerve stimulation (Paired VNS) device. The FDA-approved Vivistim Paired VNS System combines VNS with upper limb rehabilitation to reduce upper-extremity motor deficits and improve function in chronic stroke survivors.

Design: Observational, postmarket patient registry collecting outcomes data from individuals who receive Vivistim for stroke recovery. Assessments will be conducted at baseline and at scheduled assessment timepoints over a period of up to 3 years.

Participants: Adults aged 18 years or older with a history of stroke with moderate-to-severe upper limb deficits and clinically evaluated as appropriate candidates for Paired VNS Therapy.

Outcome measures: Motor outcome assessments include the Fugl-Meyer Assessment-Upper Extremity, the Nine Hole Peg Test, and the Wolf Motor Function Test (optional). Patient-reported outcome assessments include a global quality of life questionnaire, Stroke Impact Scale, Motor Activity Log, and Beck Depression Inventory.

Conclusions: The registry is designed to provide real-world evidence on the use and outcomes of Paired VNS. These data will characterize functional changes, patient experiences, and therapy utilization in a heterogeneous chronic stroke population, supporting optimization and broader integration of Paired VNS into stroke recovery pathways.

Clinical trial registration: https://clinicaltrials.gov/study/NCT05301140, identifier NCT05301140.