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OpenTrials
Completed

NCT Number: NCT05608629

Vagus Nerve Stimulation as Treatment for Long Covid

Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Chronic Fatigue Syndrome Coronaviridae Infections Coronavirus Infections Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Infections Lung Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

Patients who have had COVID and who fulfill criteria for chronic fatigue syndrome will sign IC and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. Subjects will be called two, four and six weeks after beginning participation [application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day] to ask about adverse events. At the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients had to have had COVID
  • Patients have to fulfill the 1994 case definition for chronic fatigue syndrome.

Exclusion criteria

  • BMI > 30

Treatment and study plan

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Device

The parasym is a system for delivering a fixed signal to stimulate the auricular branch of the vagus nerve. The device used is available without prescription in UK and EU. Similar devices have been used to treat migraine and one is in testing to be used for atrial fibrillation.

Primary outcomes

  1. Number of Participants With Treatment Success

    Time frame: Baseline to post-treatment at 6-weeks

    Treatment success is defined as patient had to improve on 2 of the following:

    a 14% improvement in SF-36 -- physical function (0-100 scale, higher score = less disability;

    report of marked or moderate improvement (2-3 on a scale going from +3 to -3] based on the treatment [patient global indication of change (0-7, higher score = more improvement);

    going from fatigue case to no fatigue on Chalder fatigue scale (0-3, higher score = more fatigue;

    improvement on VAS of at least 2 points [VAS going from none [0] to 5 [very severe] with at least a 3 [substantial] on one of the following Sx --> fatigue, brain fog, widespread pain

Secondary outcomes

  1. Number of Participants With Change in the Profile of Mood States (POMS)

    Time frame: 6 weeks

    Number of participants with reductions of at least 10 points on the short version of the Profile of Mood States. The POMS ranges from 0 -120. Higher score indicates poorer health outcomes.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2022
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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