Vagus Nerve Stimulation as Treatment for Long Covid

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Transcutaneous Non-Invasive Vagus Nerve Stimulation	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Success	Baseline to post-treatment at 6-weeks	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

Name	Time	Method
Number of Participants With Change in the Profile of Mood States (POMS)	6 weeks	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.