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NCT05694663 · ClinicalTrials.gov registry record
Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
A clinical trial of Chronic Ischemic Stroke, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT05694663: Recruiting study of Chronic Ischemic Stroke, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05694663 is a study of Chronic Ischemic Stroke that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05694663, a study of Chronic Ischemic Stroke, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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, wher
Conditions Studied
Interventions
- DEVICE Vivistim
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2028-02 |
What NCT05694663 shows while recruiting
NCT05694663 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 1 condition, with Chronic Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which Vivistim is the first listed.
NCT05694663 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05694663 about?
NCT05694663 is a clinical study titled "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 procedur...
What is the current status of trial NCT05694663?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2024-10-09. Estimated completion is 2028-02.
What conditions does trial NCT05694663 study?
This clinical trial studies the following conditions: Chronic Ischemic Stroke.
What interventions are being tested in trial NCT05694663?
The interventions under investigation include: Vivistim (DEVICE).
Who is sponsoring clinical trial NCT05694663?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05694663 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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