NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Covid19; Coronavirus

Treatments: Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group; Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04638673

U54GM104941-08 (U.S. NIH Grant/Contract)

00101270

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups

Active-Active Stimulation Group

Experimental 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.

Treatment:

Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group

Sham-Active Stimulation Group

Sham Comparator group

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.

Treatment:

Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group