What side effects are associated with this type of intervention?

Non-invasive vagus nerve stimulation (nVNS) for Post-COVID Syndrome is generally well-tolerated, with mild side effects such as a warm sensation, arm or hand numbness, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. Acupuncture, another treatment that modulates the autonomic nervous system, is also considered safe with minimal adverse effects, primarily involving mild discomfort at the needle insertion sites. Both treatments have shown potential benefits with a low risk of serious adverse events.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Post-COVID Syndrome that are similar to non-invasive vagus nerve stimulation (nVNS). The context mentions ongoing trials and studies evaluating the efficacy of nVNS for conditions like episodic migraine and its potential benefits for autonomic nervous system modulation, but it does not provide details on FDA approvals for Post-COVID Syndrome treatments. Therefore, while nVNS is being studied for its potential benefits, it has not yet received FDA approval specifically for Post-COVID Syndrome.

What other types of research exist?

Promising alternatives to non-invasive vagus nerve stimulation for post-COVID syndrome patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing migraine pain intensity and is approved in multiple countries. 2) Remote electrical neuromodulation, which involves nonpainful electrical skin stimulation and has demonstrated effectiveness in reducing acute migraine pain. 3) Acupuncture, particularly at the Neiguan (P6) point, which has been shown to increase vagal modulation and improve heart rate variability measures. These alternatives have demonstrated potential in modulating the autonomic nervous system and could be considered for post-COVID syndrome treatment.

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Device

Vagus Nerve Stimulation for Post-COVID Syndrome

N/A

Waitlist Available

Led By David Putrino, PT, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

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 week 12

Awards & highlights

Summary

This trial will test a portable device that sends gentle electrical pulses to a nerve in the neck to help people with Long COVID. The goal is to see if this can reduce their symptoms by calming their body's stress response.

Who is the study for?

This trial is for adults over 18 who have developed dysautonomia after COVID-19, can speak English, and are willing to follow the study rules. It's not for pregnant or breastfeeding individuals, those with heart disease, bradycardia, vagus nerve surgery in the neck, artery narrowing, undiagnosed pain syndromes or active implants.

What is being tested?

The study tests non-invasive vagus nerve stimulation against a sham (fake) intervention to see if it helps Long COVID symptoms and improves autonomic nervous system function. It's a placebo-controlled trial with random assignment and participants will experience both interventions.

What are the potential side effects?

While specific side effects aren't listed here, non-invasive vagus nerve stimulation may cause discomfort at the site of application or changes in heart rate or blood pressure due to its effect on the autonomic nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite Dysautonomia Symptom Score (COMPASS 31)

Secondary study objectives

EQ-5D-5L Quality of Life Score

End-tidal CO2 levels

Fatigue Severity Scale (FSS)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Non-invasive Vagus Nerve StimulationExperimental Treatment1 Intervention

Participants in the Non-Invasive Vagus Nerve Stimulation arm will have devices calibrated to a therapeutic setting.

Group II: Sham Vagus Nerve StimulationPlacebo Group2 Interventions

Participants in the "sham VNS" arm will be asked to use the VNS device daily on a sham setting for six weeks and will be given the opportunity to "crossover" into the active VNS arm once they have completed the sham arm.

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

Non-invasive vagus nerve stimulation (VNS) is a promising treatment for Post-COVID Syndrome that works by modulating the autonomic nervous system. This method aims to restore balance between the sympathetic and parasympathetic nervous systems, which can be disrupted in Post-COVID patients, leading to symptoms such as fatigue, dyspnea, and anxiety. By stimulating the vagus nerve, VNS can potentially alleviate these symptoms, thereby improving the overall quality of life and functional capacity of individuals suffering from Post-COVID Syndrome.

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

886 Previous Clinical Trials

535,003 Total Patients Enrolled

David Putrino, PT, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

5 Previous Clinical Trials

425 Total Patients Enrolled

Media Library

Non-invasive vagus nerve stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05630040 — N/A

Post-COVID Syndrome Research Study Groups: Non-invasive Vagus Nerve Stimulation, Sham Vagus Nerve Stimulation

Post-COVID Syndrome Clinical Trial 2023: Non-invasive vagus nerve stimulation Highlights & Side Effects. Trial Name: NCT05630040 — N/A

Non-invasive vagus nerve stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630040 — N/A

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