Clinical trial NCT05254080: taVNS Cold Pressor
Official title: Assessing the Physiologic Effect of taVNS During a Cold Pressor Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: taVNS
Brain Stimulation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. During the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. Researchers will measure participant's heart rate while they receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65 years
* English speaking
* Non-treatment-seeking community members

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 a reported history of any mental health disorder or taking any psychotropic medications.
* Moderate to severe alcohol or substance use disorder.
* Pregnancy

Primary outcomes:
measure: Mean Heart Rate (Before CPT/taVNS)
timeFrame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
measure: Mean Heart Rate (During CPT/taVNS)
timeFrame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
measure: Mean Heart Rate (After CPT/taVNS)
timeFrame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Secondary outcomes:
measure: Mean Score of Pain (Before CPT/taVNS)
timeFrame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
measure: Mean Score of Pain (During CPT/taVNS)
timeFrame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
measure: Mean Score of Pain (After CPT/taVNS)
timeFrame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
measure: Mean Score of Anxiety (Before CPT/taVNS)
timeFrame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
measure: Mean Score of Anxiety (During CPT/taVNS)
timeFrame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
measure: Mean Score of Anxiety (After CPT/taVNS)
timeFrame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
measure: Mean Score of Distress (Before CPT/taVNS)
timeFrame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
measure: Mean Score of Distress (During CPT/taVNS)
timeFrame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
measure: Mean Score of Distress (After CPT/taVNS)
timeFrame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Christopher W Austelle, MD
role: PRINCIPAL_INVESTIGATOR
References: