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VNS for Long-COVID-19

NCT05630040 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-08

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Sham Intervention

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

Sponsors & Collaborators

Principal Investigators

  • David Putrino, PT, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2024-10-03
Completion
2024-10-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630040 on ClinicalTrials.gov