NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
2 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2020
CompletedStudy Start
First participant enrolled
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
July 26, 2022
CompletedJuly 26, 2022
July 1, 2022
7 months
November 18, 2020
June 20, 2022
July 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Active-Active Stimulation Group
EXPERIMENTALThis 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.
Sham-Active Stimulation Group
SHAM COMPARATORThis 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.
Interventions
Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.
Eligibility Criteria
You may qualify if:
- COVID positive
- At home
- Afebrile
- Anxiety
- Depression
- Vertigo
- Anosmia
- Headaches
- Irritability
- Cognitive Processing
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (2)
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.
PMID: 36002874DERIVEDBadran 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 [Preprint]. 2022 Jun 21:rs.3.rs-1716096. doi: 10.21203/rs.3.rs-1716096/v1.
PMID: 35765566DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mark S. George
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S George, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished University Professor
Study Record Dates
First Submitted
November 18, 2020
First Posted
November 20, 2020
Study Start
November 19, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
July 26, 2022
Results First Posted
July 26, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share