Home Operations Utilizing Stimulation

Cognitive Performance Clinical Trial

Official title:

Home Operations Utilizing Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484285
• Other study ID #: IRB201901518 -A
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: September 6, 2023

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: Eric Porges, PhD
• Phone: 352-294-5838
• Email: eporges[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance.

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 cognitive performance. Vagal nerve stimulation (VNS) has been indicated to improve stress response and to enhance neuroplasticity by directly impacting brain structures critical for cognition. Historically, VNS methods required neurosurgery and were reserved for medically intractable epilepsy or other severe conditions. Today, vagal nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will utilize a home-operated stimulator in healthy young adult and healthy older populations to provide a proof of concept of practical home-use stimulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Performance

Intervention

Device:
• Transcutaneous Vagal Nerve Stimulation (tVNS)
vagal nerve stimulation

Locations

Country	Name	City	State
United States	University of Florida McKnight Brain Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Scale	This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree).	Up through Day 7