Vagus Nerve Stimulation as Treatment for Long Covid

NCT05608629 | Completed Results

• 1 other identifier: STUDY-21-01846
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 weeks

Study Arms (1)

Transcutaneous Non-Invasive Vagus Nerve Stimulation

EXPERIMENTAL

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

Interventions

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.

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• BMI \> 30

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Benjamin H Natelson
• Organization: Icahn School of Medicine at Mount Sinai

Benjamin.Natelson@mountsinai.org

(212) 844-6665

Study Officials

• Benjamin Natelson, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: 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

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 8, 2022
• Study Start: June 6, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: January 8, 2024
• Results First Posted: January 8, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.)

Locations

US (1)