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OpenTrials
Completed

NCT Number: NCT04638673

NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.

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Key information

Conditions

Coronavirus COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID positive
  • At home
  • Afebrile
  • Anxiety
  • Depression
  • Vertigo
  • Anosmia
  • Headaches
  • Irritability
  • Cognitive Processing

Exclusion criteria

  • Damage to left ear anatomy
  • Unstable hemodynamic effects
  • Ischemic or hemorrhagic stroke after developing COVID
  • Unable to give consent, follow instructions
  • Unable to read or write or speak English
  • No access to home WiFi

Treatment and study plan

Soterix taVNS model 0125-LTE Stimulator - Active-Active Group

Device

Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.

Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group

Device

Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.

Primary outcomes

  1. Change in Score of Patient Health Questionnaire-9

    Time frame: Baseline and week 4 (End of Treatment)

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms.

    Remission -minimal to absence of symptoms; PHQ-9 score < 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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