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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome; Long COVID
• Intervention / Treatment: Device: Transcutaneous Non-Invasive Vagus Nerve Stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• BMI > 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Non-Invasive Vagus Nerve Stimulation; Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day	Device: Transcutaneous Non-Invasive Vagus Nerve Stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Success	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	Baseline to post-treatment at 6-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Change in the Profile of Mood States (POMS)	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.	6 weeks

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Benjamin Natelson, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Chronic Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; COVID-19; Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: STUDY-21-01846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to benjamin.natelson@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be determined.)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No