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Device

Vagus Nerve Stimulation for Post-COVID Syndrome

N/A
Waitlist Available
Led By David Putrino, PT, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial will study how a non-invasive stimulation of the vagus nerve affects long COVID symptoms and biomarkers. 40 people with long COVID will receive a placebo or the stimulation.

Who is the study for?
This trial is for adults over 18 who have developed dysautonomia after COVID-19, can speak English, and are willing to follow the study rules. It's not for pregnant or breastfeeding individuals, those with heart disease, bradycardia, vagus nerve surgery in the neck, artery narrowing, undiagnosed pain syndromes or active implants.Check my eligibility
What is being tested?
The study tests non-invasive vagus nerve stimulation against a sham (fake) intervention to see if it helps Long COVID symptoms and improves autonomic nervous system function. It's a placebo-controlled trial with random assignment and participants will experience both interventions.See study design
What are the potential side effects?
While specific side effects aren't listed here, non-invasive vagus nerve stimulation may cause discomfort at the site of application or changes in heart rate or blood pressure due to its effect on the autonomic nervous system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Dysautonomia Symptom Score (COMPASS 31)
Secondary outcome measures
EQ-5D-5L Quality of Life Score
End-tidal CO2 levels
Fatigue Severity Scale (FSS)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-invasive Vagus Nerve StimulationExperimental Treatment1 Intervention
Participants in the Non-Invasive Vagus Nerve Stimulation arm will have devices calibrated to a therapeutic setting.
Group II: Sham Vagus Nerve StimulationPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,246 Total Patients Enrolled
David Putrino, PT, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
425 Total Patients Enrolled

Media Library

Non-invasive vagus nerve stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05630040 — N/A
Post-COVID Syndrome Research Study Groups: Non-invasive Vagus Nerve Stimulation, Sham Vagus Nerve Stimulation
Post-COVID Syndrome Clinical Trial 2023: Non-invasive vagus nerve stimulation Highlights & Side Effects. Trial Name: NCT05630040 — N/A
Non-invasive vagus nerve stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630040 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being recruited for this trial at the moment?

"Per the information on clinicaltrials.gov, this research is currently accepting applicants. The study was initially advertised on November 11th 2022 and has been updated as recently as November 21st 2022."

Answered by AI

What is the current participant count for this examination?

"Affirmative. Information hosted on clinicaltrials.gov reveals that the trial, inaugurated on November 11th 2022 is currently recruiting participants. 40 patients must be recruited from 1 facility to complete this project."

Answered by AI

Who else is applying?

What site did they apply to?
Abilities Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
VNS for Long-COVID-19
David Putrino 2022. "VNS for Long-COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630040.
~2 spots leftby Jun 2024
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