NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Primary Purpose
Coronavirus, Covid19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group
Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active-Active Stimulation Group
Sham-Active Stimulation Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04638673
First Posted
November 18, 2020
Last Updated
July 25, 2022
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT04638673
Brief Title
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Official Title
Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active-Active Stimulation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-Active Stimulation Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group
Intervention Description
Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
Intervention Type
Device
Intervention Name(s)
Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group
Intervention Description
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 Outcome Measure Information:
Title
Change in Score of Patient Health Questionnaire-9
Description
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.
Time Frame
Baseline and week 4 (End of Treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S George, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36002874
Citation
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.
Results Reference
derived
PubMed Identifier
35765566
Citation
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.
Results Reference
derived
Learn more about this trial
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
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