Learning, taVNS
Conditions
Brief summary
This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours. Researchers will measure brain waves and other body responses (heart rate), while while the ear is stimulated. Participants also will be asked to complete computer tasks. Because brain activity will be measured, participants will be asked to come to the study with clean, dry hair. The study is at MUSC in Charleston. Participants will be compensated for their time. To be eligible, participants must be 18-65 years old, be able to commit 2.5 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer. There are some risks to completing this study. Some questions in the surveys ask about personal thoughts and feelings. The ear stimulation may cause tingling sensations or irritation around the ear. There are no direct benefits to participants. This study will help researchers improve this ear stimulation as a treatment method.
Interventions
DEVICEtranscutaneous auricular vagus nerve stimulation (taVNS) 15 minutes
Sham 60 minutes and taVNS active stimulation for 15 minutes
DEVICEtaVNS 30 minutes
Sham 45 minutes and taVNS active stimulation for 30 minutes
DEVICEtaVNS 45 minutes
Sham 30 minutes and taVNS active stimulation for 45 minutes
DEVICEtaVNS 60 minutes
Sham 15 minutes and taVNS active stimulation for 60 minutes
DEVICEtaVNS 75 minutes
Sham 0 minutes and taVNS active stimulation for 75 minutes
DEVICEtaVNS 0 minutes
Sham taVNS 75 minutes
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * Non-treatment-seeking community members who do not have a mental health diagnosis and individuals seeking treatment for an anxiety, mood, trauma-related, or obsessive-compulsive disorder. * Treatment and non-treatment-seeking community members with anxiety, mood, trauma-related, or obsessive-compulsive disorder or symptoms.
Exclusion criteria
* Diagnosis of COVID-19 in the past 14 days * Facial or ear pain or recent ear trauma * Metal implant devices in the head, heart or neck * History of brain stimulation or other brain surgery * History of myocardial infarction or arrhythmia, bradycardia * Use of B-blockers, antiarrhythmic medication (sodium/potassium/calcium-channel blockers), or blood pressure medications. * Active respiratory disorder * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium). * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury * Individuals suffering from frequent/severe headaches * Individuals with lifetime evidence of severe psychiatric disorder (e.g., schizophrenia) or neurological disorder. * Moderate to severe alcohol or substance use disorder. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in P300 Amplitude | Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes | Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation. |
| Change in Heart Rate Variability | Baseline to end of Active Stimulation | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Group 1 transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes | 6 |
| Dose Group 2 taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes | 6 |
| Dose Group 3 taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes | 5 |
| Dose Group 4 taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes | 6 |
| Dose Group 5 taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes | 5 |
| Total | 28 |
Baseline characteristics
| Characteristic | Dose Group 1 | Dose Group 2 | Dose Group 3 | Dose Group 4 | Dose Group 5 | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 28 Participants |
| Age, Continuous | 31.8 years STANDARD_DEVIATION 8.4 | 34.5 years STANDARD_DEVIATION 12.3 | 38.2 years STANDARD_DEVIATION 16.9 | 32.7 years STANDARD_DEVIATION 15.9 | 26.8 years STANDARD_DEVIATION 3 | 32.9 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 28 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Change in Heart Rate Variability
Time frame: Baseline to end of Active Stimulation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose Group 1 | Change in Heart Rate Variability | 2.9 ms | Standard Deviation 1.6 |
| Dose Group 2 | Change in Heart Rate Variability | 1.9 ms | Standard Deviation 0.7 |
| Dose Group 3 | Change in Heart Rate Variability | 1.5 ms | Standard Deviation 1.1 |
| Dose Group 4 | Change in Heart Rate Variability | 1.3 ms | Standard Deviation 0.2 |
| Dose Group 5 | Change in Heart Rate Variability | 1.7 ms | Standard Deviation 0.6 |
Primary
Change in P300 Amplitude
Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.
Time frame: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose Group 1 | Change in P300 Amplitude | .88 microvolts | Standard Deviation 2.01 |
| Dose Group 2 | Change in P300 Amplitude | .50 microvolts | Standard Deviation 1.4 |
| Dose Group 3 | Change in P300 Amplitude | -.15 microvolts | Standard Deviation 1.8 |
| Dose Group 4 | Change in P300 Amplitude | -.26 microvolts | Standard Deviation 0.61 |
| Dose Group 5 | Change in P300 Amplitude | .23 microvolts | Standard Deviation 1.4 |