VALOR Registry: Vagal Nerve Stimulation for Stroke Recovery
This study, called the VALOR Registry, is looking at the safety of a treatment called Vagal Nerve Stimulation (VNS) using the Vivistim device for people who have had a chronic ischemic stroke (a stroke caused by a blood clot) and still have weakness in their arm. VNS involves a small device surgically placed to send mild electrical pulses to a nerve in your neck. The study will monitor patients at Mount Sinai Health System who are already planning to get this device. We want to see if there are any serious problems from the surgery or the rehabilitation that goes with it. Success will be measured by improvements in arm movement, specifically using a test called the Fugl Meyer Assessment - Upper Extremity (FMA-UE) over about a year. The study plans to enroll 40 participants.
- Study design
- This is an observational study, meaning researchers will watch and collect information from participants already undergoing VNS treatment. It plans to enroll 40 participants.
- What's involved
- After one month of pre-rehabilitation training, you would undergo surgery to implant the Vivistim VNS device. You would then participate in a rehabilitation program.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your arm movement will be assessed from the start of the study up to day 390 after the device is implanted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christopher P Kellner, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- David Putrino, PT, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- Fedor Panov, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- Jenna Tosto, PT, DPT, NCS · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Fugl Meyer Assessment - Upper Extremity (FMA-UE)Baseline up to day 390
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index for the upper extremities. It is designed to assess motor functioning in patients with post-stroke hemiplegia of the upper limbs. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total scores range from 0-66, where higher scores indicate better performance.