NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

Phase 2

Completed

• Conditions: Coronavirus; Covid19
• Interventions: Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group; Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group

• Registration Number: NCT04638673
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-18
• Study Start: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2022-06-20
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-25
• Results First Posted: 2022-07-26
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-Active Stimulation Group	Soterix taVNS model 0125-LTE Stimulator - Sham-Active 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.
Active-Active Stimulation Group	Soterix taVNS model 0125-LTE Stimulator - Active-Active 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.

Primary Outcome Measures

Name	Time	Method
Change in Score of Patient Health Questionnaire-9	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States