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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04534556
The ClinicalTrials.gov registry entry for NCT04534556 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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