NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638673
• Other study ID #: 00101270
• Secondary ID: U54GM104941-08
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Covid19

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)