Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent pair
| Condition(s) | Chronic Ischemic Stroke |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. This registry will monitor patients undergoing VNS for stroke recovery in the Mount Sinai Health System and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery. |
| Who can participate | Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program * Aged 18 or older * History of ischemic stroke * Upper extremity weakness * Planned to undergo VNS implantation Exclusion Criteria: * Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.). * Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Locations | New York, New York, United States |
| Start date | 2024-10-09 |
| NCT ID | NCT05694663 |
| Official listing | https://clinicaltrials.gov/study/NCT05694663 |