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 three 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 number: NCT05301140.