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

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.