Phase 2 N=12 Randomized Triple-blind Treatment

NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

Coronavirus · Covid19

Bottom Line

View on ClinicalTrials.gov: NCT04638673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Change in Score of Patient Health Questionnaire-9 — -8.7; -5.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group (Device); Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Score of Patient Health Questionnaire-9	-8.7; -5.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04638673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.