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NCT04638673 · ClinicalTrials.gov registry record · Phase 2
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04638673: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT04638673 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04638673, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
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 s
Interventions
- DEVICE Soterix taVNS model 0125-LTE Stimulator - Active-Active Group
- DEVICE Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 2 |
What the finished NCT04638673 record still lists
NCT04638673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Soterix taVNS model 0125-LTE Stimulator - Active-Active Group is the first listed.
NCT04638673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04638673 about?
NCT04638673 is a clinical study titled "NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis". 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...
What is the current status of trial NCT04638673?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2020-11-19. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04638673?
The interventions under investigation include: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group (DEVICE), Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group (DEVICE).
Who is sponsoring clinical trial NCT04638673?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04638673's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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