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
Sponsored by
About this trial
This is an interventional treatment trial for Long COVID
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
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
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
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
No
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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