N/A N=24 Randomized Double-blind Basic Science

taVNS Cold Pressor

taVNS · Brain Stimulation

Bottom Line

View on ClinicalTrials.gov: NCT05254080 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Mean Heart Rate (Before CPT/taVNS) — 72.86; 72.0 beats per minute

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active taVNS (Device); Sham taVNS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Heart Rate (Before CPT/taVNS)	72.86; 72.0	—
PRIMARY Mean Heart Rate (During CPT/taVNS)	83.54; 83.96	—
PRIMARY Mean Heart Rate (After CPT/taVNS)	68.97; 68.78	—
SECONDARY Mean Score of Pain (Before CPT/taVNS)	0.05; 0	—
SECONDARY Mean Score of Pain (During CPT/taVNS)	5.67; 5.62	—
SECONDARY Mean Score of Pain (After CPT/taVNS)	0.24; 0.10	—
SECONDARY Mean Score of Anxiety (Before CPT/taVNS)	1.43; 1.81	—
SECONDARY Mean Score of Anxiety (During CPT/taVNS)	3.52; 3.48	—
SECONDARY Mean Score of Anxiety (After CPT/taVNS)	0.48; 0.62	—
SECONDARY Mean Score of Distress (Before CPT/taVNS)	0.29; 0.33	—
SECONDARY Mean Score of Distress (During CPT/taVNS)	4.52; 4.48	—
SECONDARY Mean Score of Distress (After CPT/taVNS)	0.05; 0.14	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05254080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.