Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-11-11
2024-10-03
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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).
TREATMENT
DOUBLE
Study Groups
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Non-invasive Vagus Nerve Stimulation
Participants in the Non-Invasive Vagus Nerve Stimulation arm will have devices calibrated to a therapeutic setting.
Non-invasive vagus nerve stimulation
Participants will take the VNS device home and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for 6 weeks.
Sham Vagus Nerve Stimulation
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.
Non-invasive vagus nerve stimulation
Participants will take the VNS device home and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for 6 weeks.
Sham Intervention
Participants will take a placebo device home for 6 weeks and use daily.
Interventions
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Non-invasive vagus nerve stimulation
Participants will take the VNS device home and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for 6 weeks.
Sham Intervention
Participants will take a placebo device home for 6 weeks and use daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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David Putrino
Director of Rehabilitation Innovation, Mount Sinai Health System Associate Professor of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai
Principal Investigators
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David Putrino, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Abilities Research Center
New York, New York, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY-22-00985
Identifier Type: -
Identifier Source: org_study_id
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