NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04638673
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of General Medical Sciences (NIGMS) (NIH)
• Enrollment: 13
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus; Covid19	Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group; Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
• Actual Study Start Date: Nov 19, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Mark S George, MD, Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 22, 2021
• Informed Consent Form - Dec 22, 2020

More Information

Publications

None provided.

• Responsible Party: Mark S. George , MD, Distinguished University Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT04638673
• Other Study ID Numbers: 00101270; U54GM104941-08
• First Posted: Nov 20, 2020
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Recruitment Details	One participant was removed after consent for failure to satisfy all inclusion requirements.

Arm/Group Title	Active-Active Stimulation Group	Sham-Active Stimulation Group
Arm/Group 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. 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.	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. 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.
Period Title: Overall Study
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active-Active Stimulation Group	Sham-Active Stimulation Group	Total
Arm/Group 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. 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.	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. 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.	Total of all reporting groups
Overall Participants	6	6	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (10.2)	46.2 (12.0)	48.3 (10.8)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	6 100%	8 66.7%
Male	4 66.7%	0 0%	4 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	6 100%	6 100%	12 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	6 100%	6 100%	12 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%	6 100%	12 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active-Active Stimulation Group	Sham-Active Stimulation Group
Arm/Group 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. 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.	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. 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.
Measure Participants	6	6
Mean (Standard Deviation) [score on a scale]	-8.7 (6.3)	-5.5 (4.1)

Adverse Events

Time Frame	4 weeks (duration of taVNS stimulation period)
Arm/Group Title	Active-Active Stimulation Group		Sham-Active Stimulation Group
Arm/Group 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. 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.		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. 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.
All Cause Mortality
	Active-Active Stimulation Group		Sham-Active Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		2/6 (33.3%)
Serious Adverse Events
	Active-Active Stimulation Group		Sham-Active Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Active-Active Stimulation Group		Sham-Active Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		2/6 (33.3%)
Skin and subcutaneous tissue disorders
Skin Irritation/Redness	0/6 (0%)	0	2/6 (33.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.