Clinical trial NCT05630040: VNS for Long-COVID-19
Official title: Vagus Nerve Simulation for Long-COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Postural Tachycardia Syndrome
Dysautonomia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a placebo controlled, double blind, randomized control trial with a crossover design built in.

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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Dysautonomia Symptom Score (COMPASS 31)
timeFrame: Baseline (Week 0)
measure: Composite Dysautonomia Symptom Score (COMPASS 31)
timeFrame: Week 2
measure: Composite Dysautonomia Symptom Score (COMPASS 31)
timeFrame: Week 5
measure: Composite Dysautonomia Symptom Score (COMPASS 31)
timeFrame: Week 8
measure: Composite Dysautonomia Symptom Score (COMPASS 31)
timeFrame: Week 12
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline (Week 0)
measure: Fatigue Severity Scale (FSS)
timeFrame: Week 2
measure: Fatigue Severity Scale (FSS)
timeFrame: Week 5
measure: Fatigue Severity Scale (FSS)
timeFrame: Week 8
measure: Fatigue Severity Scale (FSS)
timeFrame: Week 12
measure: Neuro Quality of Life Score
timeFrame: Baseline (Week 0)
measure: Neuro Quality of Life Score
timeFrame: Week 2
measure: Neuro Quality of Life Score
timeFrame: Week 5
measure: Neuro Quality of Life Score
timeFrame: Week 8
measure: Neuro Quality of Life Score
timeFrame: Week 12
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: Baseline (Week 0)
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: Week 2
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: Week 5
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: Week 8
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: Week 12
measure: Post-Exertional Malaise (PEM) Screener
timeFrame: Baseline (Week 0)
measure: Post-Exertional Malaise (PEM) Screener
timeFrame: Week 2
measure: Post-Exertional Malaise (PEM) Screener
timeFrame: Week 5
measure: Post-Exertional Malaise (PEM) Screener
timeFrame: Week 8
measure: Post-Exertional Malaise (PEM) Screener
timeFrame: Week 12
measure: EQ-5D-5L Quality of Life Score
timeFrame: Baseline (Week 0)
measure: EQ-5D-5L Quality of Life Score
timeFrame: Week 2
measure: EQ-5D-5L Quality of Life Score
timeFrame: Week 5
measure: EQ-5D-5L Quality of Life Score
timeFrame: Week 8
measure: EQ-5D-5L Quality of Life Score
timeFrame: Week 12
measure: Plasma IL-6 levels
timeFrame: Baseline (Week 0)
measure: Plasma IL-6 levels
timeFrame: Week 2
measure: Plasma IL-6 levels
timeFrame: Week 5
measure: Plasma IL-6 levels
timeFrame: Week 8
measure: Plasma IL-6 levels
timeFrame: Week 12
measure: Plasma IL-1 levels
timeFrame: Baseline (Week 0)
measure: Plasma IL-1 levels
timeFrame: Week 2
measure: Plasma IL-1 levels
timeFrame: Week 5
measure: Plasma IL-1 levels
timeFrame: Week 8
measure: Plasma IL-1 levels
timeFrame: Week 12
measure: Plasma IL-10 levels
timeFrame: Baseline (Week 0)
measure: Plasma IL-10 levels
timeFrame: Week 2
measure: Plasma IL-10 levels
timeFrame: Week 5
measure: Plasma IL-10 levels
timeFrame: Week 8
measure: Plasma IL-10 levels
timeFrame: Week 12
measure: Plasma HS-CRP levels
timeFrame: Baseline (Week 0)
measure: Plasma HS-CRP levels
timeFrame: Week 2
measure: Plasma HS-CRP levels
timeFrame: Week 5
measure: Plasma HS-CRP levels
timeFrame: Week 8
measure: Plasma HS-CRP levels
timeFrame: Week 12
measure: Morning salivary cortisol levels
timeFrame: Baseline (Week 0)
measure: Morning salivary cortisol levels
timeFrame: Week 2
measure: Morning salivary cortisol levels
timeFrame: Week 5
measure: Morning salivary cortisol levels
timeFrame: Week 8
measure: Morning salivary cortisol levels
timeFrame: Week 12
measure: End-tidal CO2 levels
timeFrame: Baseline (Week 0)
measure: End-tidal CO2 levels
timeFrame: Week 2
measure: End-tidal CO2 levels
timeFrame: Week 5
measure: End-tidal CO2 levels
timeFrame: Week 8
measure: End-tidal CO2 levels
timeFrame: Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Abilities Research Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: