Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain
CompletedNot applicableNCT04053127
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain
- Conditions
- Interventions
- Device: RAVANS
- Sponsor
- Brigham and Women's Hospital
- Start date
- 2019-04-01
- Primary completion
- 2020-08-01
- Sex
- All
- Age range
- from 21 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. age 21-65. 2. chronic pain lasting for more than 6 months as the primary complaint. 3. typical pain ratings ≥ 3/10 on a visual analogue scale. 4. able to speak and understand English. Exclusion Criteria: 1. evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures. 2. history of cardiac or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. 3. current peripheral neuropathy. 4. current pregnancy, or intention to become pregnant during the study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04053127