Home Operations Utilizing Stimulation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2023-09-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Younger Cohort

Healthy individuals aged 18 - 55

Group Type ACTIVE_COMPARATOR

Transcutaneous Vagal Nerve Stimulation (tVNS)

Intervention Type DEVICE

vagal nerve stimulation

Older Cohort

Healthy individuals aged 56 - 85

Group Type ACTIVE_COMPARATOR

Transcutaneous Vagal Nerve Stimulation (tVNS)

Intervention Type DEVICE

vagal nerve stimulation

Interventions

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Transcutaneous Vagal Nerve Stimulation (tVNS)

vagal nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes