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Vagus Nerve Stimulation for Pain Perception
N/A
Recruiting
Led By Eleni Frangos, Ph.D.
Research Sponsored by National Center for Complementary and Integrative Health (NCCIH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be between 18 and 50 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights
Study Summary
This trial is testing the effects of mood and vagus nerve stimulation on the experience of pain. Healthy people ages 18 and up who are fluent in English are eligible. There are 3 visits, each 2 hours long. The first is a screening visit, and the other 2 are testing sessions.
Who is the study for?
This trial is for healthy English-speaking adults aged 18-50 who can consent to participate. Excluded are pregnant or breastfeeding individuals, those with major medical conditions, psychiatric disorders, substance abuse issues, certain medication use, ear acupuncture history, dermatological issues on the ears, excessive alcohol consumption, chronic pain history or cardiac function concerns.Check my eligibility
What is being tested?
The study investigates how stimulating the vagus nerve at the ear affects pain perception and mood. Participants undergo a screening visit followed by two sessions of either direct vagus nerve stimulation or stimulation away from it while experiencing controlled heat pain on their forearm.See study design
What are the potential side effects?
Participants may experience mild electric shocks during ear stimulation that could cause tingling, pricking sensations or itchiness. There might also be discomfort from heat applied to the forearm and potential minor side effects from monitoring devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The difference in pain ratings collected for each subject during the two types of left ear stimulation (cymba conchae and earlobe).
Secondary outcome measures
Autonomic measures will be analyzed to determine whether tVNS has an effect on heart rate variability.
Mood and anxiety, as measured by questionnaires taken at the beginning and end of both study sessions.
The effect of tVNS on pain threshold, pain unpleasantness, and mood as measured by visual analogue scales (VAS).
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cymba ConchaeExperimental Treatment2 Interventions
Mild electrical stimulation is applied to the cymba conchae of the left ear, and thermal stimulation is applied to the arms.
Group II: Ear LobeActive Control2 Interventions
Mild electrical stimulation is applied to the earlobe of the left ear, and thermal stimulation is applied to the arms.
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Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)Lead Sponsor
832 Previous Clinical Trials
668,857 Total Patients Enrolled
Eleni Frangos, Ph.D.Principal InvestigatorNational Center for Complementary and Integrative Health (NCCIH)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow the study's schedule and procedures.I have a long-term pain condition.I have a heart condition or a problem with my blood vessels.I am currently on medication that affects pain or autonomic functions.I have had acupuncture treatments on or near my ears.I haven't used any pain-relief creams on the test area in the last 24 hours.I have taken NSAIDs, acetaminophen, or sumatriptan in the last 3 days.I am between 18 and 50 years old.I have significant health issues affecting different parts of my body.I have scars, burns, or recent tattoos where they plan to test.My ears have an unusual shape or structure due to birth defects, accidents, or surgeries.
Research Study Groups:
This trial has the following groups:- Group 1: Ear Lobe
- Group 2: Cymba Conchae
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals eligible to partake in this research experiment at present?
"Indeed, the information found on clinicaltrials.gov shows that this research is currently recruiting participants. The investigation was initially published on October 18th 2016 and its most recent update occurred on November 18th 2022. This medical trial is looking for 76 patients at one test site to participate in the study."
Answered by AI
What is the participant count for this experiment?
"Affirmative. According to information on clinicaltrials.gov, the trial is actively recruiting participants and was initially posted online in October 2016 with an update made in November 2022. This study requires 76 patient volunteers from 1 medical centre."
Answered by AI
Does this research project accommodate those above the age of four decades?
"This medical research is looking for participants aged 18 and above, but below 50 years old."
Answered by AI
What criteria must be met for participation in this clinical investigation?
"This research study is permitting 76 persons with pain and aged between 18 to 50 years old. To be eligible, they must additionally possess fluency in English and the capacity to supply written approval."
Answered by AI
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