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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Younger Cohort | Active Comparator | Healthy individuals aged 18 - 55 |
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| Older Cohort | Active Comparator | Healthy individuals aged 56 - 85 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Vagal Nerve Stimulation (tVNS) | Device | vagal nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida McKnight Brain Institute | Gainesville | Florida | 32643 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Younger Cohort | Healthy individuals aged 18 - 50 Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation completed at home for 7 days. |
| FG001 | Older Cohort | Healthy individuals aged 50 - 85 Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation completed at home for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Younger Cohort | Healthy individuals aged 18 - 50 Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation |
| BG001 | Older Cohort | Healthy individuals aged 50 - 85 Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 7 reported |
|
7 days
The study intervention utilized a stimulator designed for home use. This design has additional hardware and software features that reduces the chance of and adverse event. On the hardware, the device runs off 4 double AA batteries opposed to plugged into an outlet. On software, initiation of the device is dependent on the corresponding web portal which is programmed to limit use duration per session and to one session per day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Younger Cohort | Healthy individuals aged 18 - 50 Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation |
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The study enrolled only participant into the older adult group. This participant was unable to use the stimulator. To understand the feasibility of this intervention in this group many more older adult participants would need to be enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Porges, Associate Profressor | University of Florida | (352) 294-5838 | eporges@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2020 | Mar 26, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2020 | Mar 26, 2025 | ICF_003.pdf |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Healthy individuals aged 50 - 85
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Older Cohort | Healthy individuals aged 50 - 85 Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation | 0 | 1 | 0 | 1 | 0 | 1 |
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