VNS for Long-COVID-19

Mount Sinai Health System

Status: Completed

Conditions: Postural Tachycardia Syndrome; Post-COVID-19 Syndrome; Dysautonomia

Treatments: Device: Non-invasive vagus nerve stimulation; Device: Sham Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05630040

STUDY-22-00985

Details and patient eligibility

About

The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function.

This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.

Full description

Participants will be randomized into one of two arms. Those in the "active VNS" arm will be sent home with a portable VNS device and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for six weeks.

Those in the "sham VNS" arm will be asked to use the VNS device daily on a sham setting for six weeks. Those randomized to the sham group will be given the opportunity to "crossover" into the active VNS arm once they have completed the sham arm (Week 12). The participant and assessor will be blinded.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• At least 18 years of age

• Clinical diagnosis of dysautonomia following an acute COVID-19 infection at least 3 months prior. See below for criteria:

  • clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider

• 2 or more if the following clinical assessment findings

• symptomatic exacerbation during active stand test

• tachycardia on active stand test

• tachycardia on orthostatic vitals assessment

• hypotension on orthostatic vitals assessment

• hypertension in orthostatic vitals assessment

• symptom exacerbation on orthostatic vitals assessment

• English speaking

Exclusion criteria

• Pregnancy or lactation:

• Pregnant persons will not be included in this study for the following reasons:

  • There is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (PCD). The results could be skewed due to pregnancy.
  • Of note, there are no risks for pregnant persons to participate.

According to the device manufacturer, the following contraindications will be followed during the screening process:

• Patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic device
• Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years)
• Patients with diagnosed bradycardia
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients whose pain syndromes are undiagnosed
• Pediatric patients
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Non-invasive Vagus Nerve Stimulation

Experimental group

Description:

Participants in the Non-Invasive Vagus Nerve Stimulation arm will have devices calibrated to a therapeutic setting.

Treatment:

Device: Non-invasive vagus nerve stimulation

Sham Vagus Nerve Stimulation

Sham Comparator group

Description:

Participants in the "sham VNS" arm will be asked to use the VNS device daily on a sham setting for six weeks and will be given the opportunity to "crossover" into the active VNS arm once they have completed the sham arm.

Treatment:

Device: Sham Intervention

Device: Non-invasive vagus nerve stimulation