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NCT04053127 · ClinicalTrials.gov registry record · NA
Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT04053127 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 19 participants.
The verdict
NCT04053127, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
Vagus Nerve Stimulation (VNS) is a validated and FDA-approved therapy that has improved the lives of many individuals with epilepsy and depression and has shown promise for treating chronic pain. However, there is moderate morbidity associated with the surgical procedure and maintenance of VNS. The study team has developed a novel, non-invasive procedure based on the neurobiology of VNS treatment which is termed Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS). The investigators hope to maximize efficacy and better understand applicability of RAVANS by applying this to chronic pain patients with a range of psychiatric and psychological comorbidity. This high-distress subpopulation of chronic pain patients has been notoriously difficult to treat and is in need of new, innovative therapies. The investigators propose applying electrical stimulation of the somatosensory vagal afferent receptors in the ear using transcutaneous-VNS (t-VNS) during the exhalation phase of breathing in order to augment the clinical efficacy of t-VNS. This proposal includes a single blinded, controlled design for testing the impact of RAVANS therapy on pain and mood fro chronic pain. Patients will complete 2 in-person visits, one with RAVANS therapy and one with non-RAVANS stimulation. During each session, participants will complete questionnaires, quantitative sensory testing (QST), and receive either real or sham RAVANS stimulation.
Interventions
- DEVICE RAVANS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2020-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04053127
The ClinicalTrials.gov registry entry for NCT04053127 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RAVANS is the first listed.
NCT04053127 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04053127 about?
NCT04053127 is a clinical study titled "Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain". Vagus Nerve Stimulation (VNS) is a validated and FDA-approved therapy that has improved the lives of many individuals with epilepsy and depression and has shown promise for treating chronic pain. However, there is moderate morbidity associated with the surgical procedure and maintenance of VNS. The ...
What is the current status of trial NCT04053127?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2019-04-01. Estimated completion is 2020-08-01.
What interventions are being tested in trial NCT04053127?
The interventions under investigation include: RAVANS (DEVICE).
Who is sponsoring clinical trial NCT04053127?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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