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NCT03445754 · ClinicalTrials.gov registry record · NA
Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function in PAD
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03445754: Completed NA study, sponsored by University of Oklahoma.
NCT03445754 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03445754, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Peripheral arterial disease (PAD) constitutes a major public health burden. The incidence of PAD increases with age and is associated with other comorbid cardiovascular disorders. Atherosclerosis which underlies PAD is associated with increased arterial stiffness and an enhanced inflammatory state as evidenced by increased levels of pro-inflammatory cytokines and markers. One the earliest signs of cardiovascular disease is endothelial dysfunction which is characterized by a decreased vasodilatory capacity of the vascular endothelium and this lesion predates the development of clinical atherosclerosis. Endothelial dysfunction has been shown to be widely prevalent in PAD. It is postulated that endothelial dysfunction is due to enhanced sympathetic drive, diminished parasympathetic drive, chronic inflammatory state all of which leads to reduced nitric oxide synthase activity in the vascular endothelium with subsequent loss of vasodilatory capacity. Studies have shown endothelial dysfunction to be reversible with pharmaco-therapeutic interventions, though these interventions are associated with their own adverse effects. Stimulation of Vagal nerve increases the parasympathetic activity while suppressing sympathetic drive, decreases inflammation and enhancing nitric oxide synthase activity. Recent experimental and clinical data suggest that low-level tragus nerve stimulation (by stimulating the auricular branch of the vagus nerve located at the tragus of the external ear) may produce the same desired neuromodulator effect compared to vagus nerve stimulation. It is however unknown if Transcutaneous Vagal Stimulation (TVS) would lead to improved endothelial function as measured by flow mediated dilatation (FMD) and laser speckle contrast imaging(LSCI), a non-invasive method of measuring endothelial function or decrease in arterial stiffness as measured by Pulse Wave Analysis (PWA), in patients with PAD. The objective of this study is to determine the impact of TVS on endot
Primary Outcome
Flow mediated vasodilatation will be tested. A change in the maximal diameter of the brachial artery(in mm) will be assessed immediately(within 10 minutes) after TVNS/sham stimulation.
Interventions
- DEVICE TVS
- DEVICE Sham TVS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2020-05-30 |
| Phase | NA |
What the finished NCT03445754 record still lists
NCT03445754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which TVS is the first listed.
NCT03445754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03445754 about?
NCT03445754 is a clinical study titled "Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function in PAD". Peripheral arterial disease (PAD) constitutes a major public health burden. The incidence of PAD increases with age and is associated with other comorbid cardiovascular disorders. Atherosclerosis which underlies PAD is associated with increased arterial stiffness and an enhanced inflammatory state a...
What is the current status of trial NCT03445754?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2017-12-11. Estimated completion is 2020-05-30.
What interventions are being tested in trial NCT03445754?
The interventions under investigation include: TVS (DEVICE), Sham TVS (DEVICE).
Who is sponsoring clinical trial NCT03445754?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03445754's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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