Vagus Nerve Stimulation as Treatment for Long Covid

Mount Sinai Health System

Status: Completed

Conditions: Long COVID; Chronic Fatigue Syndrome

Treatments: Device: Transcutaneous Non-Invasive Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05608629

STUDY-21-01846

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: Under 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Transcutaneous Non-Invasive Vagus Nerve Stimulation

Experimental group

Description:

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

Treatment:

Device: Transcutaneous Non-Invasive Vagus Nerve Stimulation