VNS for Long-COVID-19

NCT05630040 | Completed FDA Device

• 1 other identifier: STUDY-22-00985
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Composite Dysautonomia Symptom Score (COMPASS 31)

  COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.

  Baseline (Week 0)

• Composite Dysautonomia Symptom Score (COMPASS 31)

  COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.

  Week 2

• Composite Dysautonomia Symptom Score (COMPASS 31)

  COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.

  Week 5

• Composite Dysautonomia Symptom Score (COMPASS 31)

  COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.

  Week 8

• Composite Dysautonomia Symptom Score (COMPASS 31)

  COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.

  Week 12

Secondary Outcomes (55)

• Fatigue Severity Scale (FSS)

  Baseline (Week 0)

• Fatigue Severity Scale (FSS)

  Week 2

• Fatigue Severity Scale (FSS)

  Week 5

• Fatigue Severity Scale (FSS)

  Week 8

• Fatigue Severity Scale (FSS)

  Week 12

Study Arms (2)

Non-invasive Vagus Nerve Stimulation

EXPERIMENTAL

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

Device: Non-invasive vagus nerve stimulation

Sham Vagus Nerve Stimulation

SHAM COMPARATOR

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.

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

Interventions

Non-invasive vagus nerve stimulation DEVICE

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.

Also known as: Vagus nerve stimulation

Non-invasive Vagus Nerve Stimulation; Sham Vagus Nerve Stimulation

Sham Intervention DEVICE

Participants will take a placebo device home for 6 weeks and use daily.

Sham Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Abilities Research Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Postural Orthostatic Tachycardia Syndrome; Autonomic Nervous System Diseases

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• David Putrino, PT, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study will have a blinded assessor and all participants will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Innovation, Mount Sinai Health System Associate Professor of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai

Model Details: 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).

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 29, 2022
• Study Start: November 11, 2022
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)