Home Operations Utilizing Stimulation

University of Florida

Status: Completed

Conditions: Cognitive Performance

Treatments: Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04484285

IRB201901518 -A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Younger Cohort

Active Comparator group

Description:

Healthy individuals aged 18 - 55

Treatment:

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Older Cohort

Active Comparator group

Description:

Healthy individuals aged 56 - 85

Treatment:

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)