Cognitive Performance
Conditions
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 nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance.
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 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.
Interventions
vagal nerve stimulation
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale | Day 7 reported | 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). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Younger Cohort Healthy individuals aged 18 - 50
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation | 9 |
| Older Cohort Healthy individuals aged 50 - 85
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation | 1 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to operate stimulator | 3 | 0 |
Baseline characteristics
| Characteristic | Younger Cohort | Older Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 0 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 1 |
| other Total, other adverse events | 0 / 9 | 0 / 1 |
| serious Total, serious adverse events | 0 / 9 | 0 / 1 |
Outcome results
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). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device.
Time frame: Day 7 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Younger Cohort | System Usability Scale | 46.25 score on a scale | Standard Deviation 18.53 |
| Older Cohort | System Usability Scale | 10 score on a scale | — |