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NCT04534556 · ClinicalTrials.gov registry record · NA
Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
A NA study of Stroke and Ischemic Stroke, sponsored by Baylor Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04534556: Recruiting NA study of Stroke and Ischemic Stroke, sponsored by Baylor Research Institute.
NCT04534556 is a NA study of Stroke and Ischemic Stroke that is actively recruiting participants, run by Baylor Research Institute. The registered enrollment target is 42 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534556, a NA study of Stroke and Ischemic Stroke, is actively recruiting participants, sponsored by Baylor Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.
Conditions Studied
Interventions
- DEVICE Active Vagus Nerve Stimulation
- DEVICE Placebo Vagus Nerve Stimulation
Study Locations (1)
Texas
- Baylor Scott & White Institute for Rehabilitation - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2027-02-25 |
| Phase | NA |
What NCT04534556 shows while recruiting
NCT04534556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Active Vagus Nerve Stimulation is the first listed.
NCT04534556 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04534556 about?
NCT04534556 is a clinical study titled "Wireless Nerve Stimulation Device To Enhance Recovery After Stroke". Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circu...
What is the current status of trial NCT04534556?
This trial is currently recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2021-09-01. Estimated completion is 2027-02-25.
What conditions does trial NCT04534556 study?
This clinical trial studies the following conditions: Stroke, Ischemic Stroke, Chronic Stroke, Upper Extremity Paresis, Hemorrhagic Stroke.
What interventions are being tested in trial NCT04534556?
The interventions under investigation include: Active Vagus Nerve Stimulation (DEVICE), Placebo Vagus Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04534556?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04534556 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04534556's enrollment target sits among peer trials
42 260th of 454 higher than 195 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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