Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Ventricular Rate Control in Patients With Persistent Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a previous study (Dalgleish et al., 2021), the investigators found that taVNS lengthens the PQ-interval in healthy study participants with regular sinus rhythm. This finding indicates that taVNS slows AV-conduction. Thus, it is reasonable to assume that taVNS may lower ventricular rate in patients with persistent atrial fibrillation. This assumption is in line with a recent study (Stavarakis et al., 2020) demonstrating reduced atrial fibrillation burden in patients with paroxysmal atrial fibrillation in response to a 6-month taVNS intervention.
The investigators hypothesize that taVNS reduces ventricular rate in patients with persistent atrial fibrillation. This hypothesis is based on the finding that taVNS lengthens the PQ-interval in healthy individuals with sinus rhythm (Dalgleish et al., 2021), demonstrating that taVNS slows AV-nodal conduction. Thus, it is conceivable that taVNS reduces the number of atrial excitations that are transmitted into the ventricles in patients with persistent atrial fibrillation. This effect should result in a lower ventricular rate. Testing this hypothesis is significant, because if the hypothesis would be verified, taVNS would have the potential to elicit an additive effect to AV-nodal blocking agents, and thus, may allow to reduce the dose of such drugs, effectively reducing potential adverse effects.
The study is designed as a two-week randomized cross-over study. Participants will start with either taVNS or sham-taVNS (randomly assigned) during the first week and then switch to the other intervention during the second week of the study. Throughout the two-week study, ambulatory ECG will be recorded using an ECG patch that allows continuous ECG recording for up to 14 days. Participants will self-apply taVNS or sham-taVNS for 30 min every day throughout the 2-week study.
Participants will meet with the investigators 3 times throughout the 2-week study protocol: On the first study day, participants will be instrumented with the ECG patch and instructed in the use of the taVNS device. In addition, patients will be instructed to keep a diary to record the time of the taVNS/sham-taVNS application, the stimulation parameters, and any potential therapeutic or adverse effects. The second study visit will occur at the end of the first study week. During this meeting, the function of the ECG patch and taVNS device will be verified, the diary will be inspected to verify protocol adherence, and the intervention will be switched to either taVNS or sham-taVNS application (depending on randomization). The final study visit will occur at the end of the study (after 2 weeks). The ECG patch will be retrieved, and the diary inspected for protocol adherence.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Harald M Stauss, MD, PhD
- Phone Number: 575-674-2327
- Email: hstauss@burrell.edu
Study Locations
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New Mexico
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Las Cruces, New Mexico, United States, 88001
- Burrell College of Osteopathic Medicine
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Contact:
- Harald M Stauss, MD, PhD
- Phone Number: 575-674-2327
- Email: hstauss@bcomnm.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age
- Persistent atrial fibrillation
- On anti-coagulation throughout the study
Exclusion Criteria:
- Below 18 years of age
- Pregnancy
- Signs or history of vestibulocochlear neuronitis or nerve damage (e.g., hearing loss or tinnitus)
- Signs or history of epilepsy
- Not on anti-coagulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Intervention
Participants will self-administer active taVNS for 30 min per day for 7 days.
|
The clip electrode will be attached to the cymba conchae of the left ear, the location of the auricular branch of the vagus nerve.
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Sham Comparator: Sham Intervention
Participants will self-administer sham-taVNS for 30 min per day for 7 days.
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The clip electrode will be attached to the lobule of the left ear that is not innervated by the auricular branch of the vagus nerve.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly ventricular rate
Time Frame: After one week of treatment or sham treatment
|
The average ventricular rate (obtained from the ECG patch) during the week with active taVNS (active intervention arm) will be compared with the average ventricular rate during the week with sham-taVNS (sham intervention arm).
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After one week of treatment or sham treatment
|
|
Ventricular rate during taVNS application
Time Frame: During 30 minutes of treatment or sham treatment
|
The ventricular rate (obtained from the ECG patch) during the 30 min of taVNS application will be compared with the ventricular rate during the 30 min of sham-taVNS application for each of the 7 days of each study arm.
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During 30 minutes of treatment or sham treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Harald M Stauss, MD, PhD, Burrell College of Osteopathic Medicine
Publications and helpful links
General Publications
- Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.
- Dalgleish AS, Kania AM, Stauss HM, Jelen AZ. Occipitoatlantal decompression and noninvasive vagus nerve stimulation slow conduction velocity through the atrioventricular node in healthy participants. J Osteopath Med. 2021 Feb 18;121(4):349-359. doi: 10.1515/jom-2020-0213.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0104_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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