Status:
COMPLETED
Home Operations Utilizing Stimulation
Lead Sponsor:
University of Florida
Conditions:
Cognitive Performance
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This project will utilize a home-operated stimulator in 1) a healthy young adult population and 2) a healthy older adult population to provide a proof of concept of home-use of transcutaneous vagal ne...
Detailed Description
The vagal nerve is a major component of the autonomic nervous system and mediates the physiological responses of major organs during moments of stress and learning, including brain areas that modulate...
Eligibility Criteria
Inclusion
- Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
- Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.
Exclusion
- Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.
- Sleep medications and/or psychostimulants are exclusionary. Subjects in the older cohort will NOT be excluded for taking blood pressure and cholesterol medication. Participants who are pregnant will be excluded. If participants have a history of adverse reaction to electrical nerve stimulation, they will be excluded.
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04484285
Start Date
August 20 2020
End Date
September 6 2023
Last Update
April 20 2025
Active Locations (1)
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1
University of Florida McKnight Brain Institute
Gainesville, Florida, United States, 32643