NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Coronavirus
• Intervention / Treatment: Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group; Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active-Active Stimulation Group; This group will be randomized into the active stimulation group for weeks 1&2 of stimulation and active stimulation during weeks 3&4 of stimulation of study participation.	Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group; Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
Sham Comparator: Sham-Active Stimulation Group; This group will be randomized into the sham stimulation group for weeks 1&2 of stimulation and active stimulation for weeks 3&4 of stimulation of study participation.	Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group; Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score of Patient Health Questionnaire-9	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.	Baseline and week 4 (End of Treatment)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

General Publications

• Badran BW, Huffman SM, Dancy M, Austelle CW, Bikson M, Kautz SA, George MS. A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms. Bioelectron Med. 2022 Aug 25;8(1):13. doi: 10.1186/s42234-022-00094-y.
• Badran BW, Huffman SM, Dancy M, Austelle CW, Bikson M, Kautz SA, George MS. A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms. Res Sq. 2022 Jun 21:rs.3.rs-1716096. doi: 10.21203/rs.3.rs-1716096/v1. Preprint.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 00101270; U54GM104941-08 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes