NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
NCT ID: NCT04638673
Last Updated: 2022-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2020-11-19
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* At home
* Afebrile
* Anxiety
* Depression
* Vertigo
* Anosmia
* Headaches
* Irritability
* Cognitive Processing
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Mark S. George , MD
Distinguished University Professor
Principal Investigators
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Mark S George, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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00101270
Identifier Type: -
Identifier Source: org_study_id
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