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Vagus Nerve Stimulation as Treatment for Long Covid

Primary Purpose

Long COVID, Chronic Fatigue Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous Non-Invasive Vagus Nerve Stimulation

About this trial

This is an interventional treatment trial for Long COVID

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients had to have had COVID Patients have to fulfill the 1994 case definition for chronic fatigue syndrome. Exclusion Criteria: BMI > 30

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Arm Description

Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day

Outcomes

Primary Outcome Measures

Change in Patient Physical Function SF-36 Score

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 Outcome Measures

Change in the Profile of Mood States (POMS)

Change of 10 or more on the Profile of Mood States which ranges from 0 -120. Higher score indicates poorer health outcomes

Full Information

NCT ID

NCT05608629

First Posted

November 4, 2022

Last Updated

February 23, 2023

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT05608629

Brief Title

Vagus Nerve Stimulation as Treatment for Long Covid

Official Title

Vagus Nerve Stimulation as Treatment for Long Covid

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 6, 2022 (Actual)

Primary Completion Date

December 5, 2022 (Actual)

Study Completion Date

December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Long COVID, Chronic Fatigue Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day for 6 weeks

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Arm Type

Experimental

Arm Description

Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day

Intervention Type

Device

Intervention Name(s)

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Intervention Description

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 Outcome Measure Information:

Title

Change in Patient Physical Function SF-36 Score

Description

Time Frame

Baseline to post-treatment at 6-weeks

Secondary Outcome Measure Information:

Title

Change in the Profile of Mood States (POMS)

Description

Change of 10 or more on the Profile of Mood States which ranges from 0 -120. Higher score indicates poorer health outcomes

Time Frame

6 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients had to have had COVID Patients have to fulfill the 1994 case definition for chronic fatigue syndrome. Exclusion Criteria: BMI > 30

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Natelson, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.)

Learn more about this trial

Vagus Nerve Stimulation as Treatment for Long Covid

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