VNS for Long-COVID-19
Completed · Not applicable · Has a placebo group
Conditions studied: Post-COVID-19 Syndrome, Postural Tachycardia Syndrome, Dysautonomia
In brief
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.
Key facts
- Study ID
- NCT05630040
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 40
- Starts
- 2022-11-11
- Expected to finish
- 2024-10-03
- Last updated by the study team
- 2024-11-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Abilities Research Center — New York, New York, United States
Full record on ClinicalTrials.gov
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