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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941-08 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-Active Stimulation Group | Experimental | 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. |
|
| Sham-Active Stimulation Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soterix taVNS model 0125-LTE Stimulator - Active-Active Group | Device | Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S George, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36002874 | Derived | 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. | |
| 35765566 | Derived | 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 [Preprint]. 2022 Jun 21:rs.3.rs-1716096. doi: 10.21203/rs.3.rs-1716096/v1. |
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One participant was removed after consent for failure to satisfy all inclusion requirements.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and week 4 (End of Treatment) |
|
4 weeks (duration of taVNS stimulation period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation/Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark S. George | Medical University of South Carolina | 843-876-5142 | georgem@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2021 | Jun 7, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2020 | Jul 12, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group | Device | Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study. |
|
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. 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. | 2 | 6 | 0 | 6 | 2 | 6 |
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| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |