What side effects are associated with this type of intervention?

Low Level Transcutaneous Vagus Nerve Stimulation (LLTS) and similar treatments like vagal nerve stimulation (VNS) are generally well-tolerated but can have mild side effects. These may include a warm sensation, tingling, redness, itching, and muscle spasms. More serious side effects are rare but can include pain in the area of stimulation and, theoretically, the risk of triggering seizures in susceptible individuals. Overall, these treatments are considered safe with a low incidence of adverse events.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure, including pharmacologic agents like beta-blockers, ACE inhibitors, and ARBs. In terms of neuromodulation, Vagus Nerve Stimulation (VNS) has been explored for its potential benefits in heart failure management. VNS involves delivering electrical impulses to the vagus nerve to improve heart function and reduce inflammation. While LLTS is still under investigation, it represents a non-invasive approach to modulating vagus nerve activity, similar to the invasive VNS techniques that have shown promise in clinical studies.

What other types of research exist?

Promising novel alternatives to LLTS for heart failure patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS) targeting different nerve pathways, 2) Spinal Cord Stimulation (SCS) which has shown benefits in chronic pain and could potentially be adapted for heart failure, and 3) Gastric Electrical Stimulation (GES) which has been used for gastroparesis and may have systemic effects. These alternatives offer non-pharmacological approaches that could be explored further in clinical settings.

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Behavioural Intervention

LLTS for Atrial Fibrillation (LLT-SPANS Trial)

N/A

Recruiting

Led By Stavros Stavrakis, MD, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment called LLTS, which uses gentle electrical impulses on the ear to help reduce irregular heartbeats and inflammation. It targets healthy volunteers, AF patients, and HFpEF patients. The treatment works by calming the heart and reducing inflammation through vagus nerve stimulation. Low-level tragus stimulation (LLTS) has been shown to significantly reduce atrial fibrillation (AF) burden in patients with paroxysmal AF.

Who is the study for?

This trial is for adults over 21, including healthy individuals and those with Paroxysmal Atrial Fibrillation or Heart Failure with Preserved Ejection Fraction. It's not for those who've had recent strokes or heart attacks, severe heart failure, are pregnant/breastfeeding, have diseases affecting the nervous system, take certain medications, have low ejection fraction in their hearts, frequent fainting spells due to vaso-vagal syncope, a history of vagus nerve surgery (vagotomy), or uncontrolled diabetes/hypertension.

What is being tested?

The study tests how different settings of Low-Level Tragus Stimulation (LLTS) affect the autonomic nervous system. Specifically looking at two frequencies (5Hz and 20Hz) and two amplitudes related to pain threshold on heart rate variability and brain stem responses in both healthy volunteers and patients with specific heart conditions.

What are the potential side effects?

While side effects aren't detailed here, LLTS may cause discomfort at the stimulation site. Since it involves electrical impulses near the ear where a branch of the vagus nerve is located, some participants might experience sensations like tingling during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart rate variability

Stress Test

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Frequency 20Hz; amplitude 1mA below discomfort thresholdExperimental Treatment1 Intervention

Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.

Group II: Frequency 20Hz; amplitude 50% below discomfort thresholdActive Control1 Intervention

Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.

Group III: Frequency 5Hz; amplitude 1mA below discomfort thresholdActive Control1 Intervention

Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.

Group IV: Frequency 5Hz; amplitude 50% below discomfort thresholdActive Control1 Intervention

Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parasym

2018

N/A

~90

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Heart failure treatments often aim to improve cardiac function and reduce symptoms by targeting various physiological pathways. Common treatments include beta-blockers, which reduce heart rate and myocardial oxygen demand; ACE inhibitors and ARBs, which lower blood pressure and decrease the workload on the heart; and diuretics, which reduce fluid overload. Low Level Transcutaneous Vagus Nerve Stimulation (LLTS) is a novel approach that modulates vagus nerve activity to improve autonomic control, reduce inflammation, and potentially decrease arrhythmia risk. This matters for heart failure patients as it offers a non-pharmacological option that can complement existing therapies, potentially improving outcomes and quality of life by addressing autonomic imbalance and inflammation, which are key contributors to heart failure progression.

Effects of transcutaneous auricular vagus nerve stimulation on cardiovascular autonomic control in health and disease.