Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain

NCT04053127 | Completed

• 1 other identifier: RAVANS_PILOT
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

vagus nerve stimulation

Outcome Measures

Primary Outcomes (2)

• Mechanical Temporal Summation

  Increases in pain with repeated mechanical stimulation

  immediately post-RAVANS stimulation

• Pressure Pain Sensitivity

  Thresholds for pressure pain assessed at several body sites

  immediately post-RAVANS stimulation

Secondary Outcomes (1)

• Pain Severity

  immediately post-RAVANS

Study Arms (2)

RAVANS

EXPERIMENTAL

Electrodes will be placed in the auricle of the left ear. Electrical stimulation to these electrodes will be provided by a current-constant stimulator (Urostim, Schwa-Medico). Stimulation will be gated, with 1-second delay, after peak inhalation (i.e. during exhalation). Respiratory gating for stimulation will require real-time evaluation of the respiratory cycle. The study will use a belt system constructed in-house, and similar to the system used in several previous studies. A pneumatic belt will be placed around the subject's lower thorax. Once electrodes are set up, subjects will be asked to rate stimulation intensity on a NRS of 0 to 10 (0: no sensation, 10: pain detection threshold). Current intensity will be set to achieve moderate to strong (but not painful) sensation, and this current intensity will be used on subsequent stimulation runs.

Device: RAVANS

non-RAVANS

SHAM COMPARATOR

For sessions randomized to sham stimulation, the electrodes in the ear will remain as described above, but the leads will be disconnected from the stimulator. Subjects will be instructed that for this session they may or may not feel pulsing in their ear, and that the goal is to ensure that the stimulus was not painful.

Device: RAVANS

Interventions

RAVANS DEVICE

Electrical stimulation of somatosensory vagal afferent receptors in the ear modulated by respiration.

Also known as: Respiratory-gated Auricular Vagal Afferent Nerve Stimulation

RAVANS; non-RAVANS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 21-65.
• chronic pain lasting for more than 6 months as the primary complaint.
• typical pain ratings ≥ 3/10 on a visual analogue scale.
• able to speak and understand English.

You may not qualify if:

• evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures.
• 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.
• current peripheral neuropathy.
• current pregnancy, or intention to become pregnant during the study.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Robert Edwards

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vitaly Napadow, Ph.D.

  MGH & BWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: August 12, 2019
• Study Start: April 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)