NCT05630040Completed
VNS for Long-COVID-19
Vagus Nerve Simulation for Long-COVID-19
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 21 Nov 2022
- Start date
- 11 Nov 2022
- Primary completion date
- 3 Oct 2024
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05630040
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 11 Nov 2022 to the primary completion date, 3 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
Other illness
- 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 whose pain syndromes are undiagnosed
Other
- Pregnancy or lactation:
- Patients with diagnosed bradycardia
- Pediatric patients
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abilities Research Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.