Effects of tVNS on Visceral Pain

NCT06659172 | Completed

• 1 other identifier: NL77976.068.21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Transcutaneous auricular vagal nerve stimulation (taVNS) has shown promise in reducing chronic abdominal pain, such as in irritable bowel syndrome (IBS). This pain is thought to result from a disruption in gut-brain communication involving the vagus nerve. Using brain imaging, we developed a pain model involving capsaicin (the spicy component in red peppers) to study this interaction. This study aims to explore how taVNS affects this pain model in healthy volunteers.

Conditions

Healthy Females; Vagus Nerve Stimulation; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Blood oxygenation level dependent BOLD signal activity in the NTS

  Main Outcome Measure The main outcome measure is the difference in Blood Oxygen Level Dependent (BOLD) response between taVNS and sham stimulation. The BOLD response is detected using fMRI, which relies on the different magnetic properties of oxygenated and deoxygenated hemoglobin. When neural tissue is more active, it receives increased blood flow, resulting in a higher percentage of oxygenated hemoglobin and a detectable change in the MRI signal. This change, known as the BOLD response, allows us to identify areas of greater neural activity. The BOLD response is a reliable indicator of brain activation.

  During fMRI

Secondary Outcomes (4)

• fMRI results

  During fMRI

• fMRI results

  During fMRI

• fMRI results

  During fMRI

• Subjective pain scores

  During fMRI

Study Arms (2)

taVNS

ACTIVE COMPARATOR

The vagus nerve will be stimulated electrically by using an MRI-safe electrode. The concha of the right ear will be stimulated.

Device: taVNS

Sham stimulation

PLACEBO COMPARATOR

The vagus nerve will be stimulated electrically by using an MRI-safe electrode. The earlobe of the right ear will be stimulated.

Device: taVNS

Interventions

taVNS DEVICE

transauricular vagus nerve stimulation

Sham stimulation; taVNS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Of female sex;
• Healthy participants (defined as those without a pre-existing medical comorbidity)
• Age between 18 and 40 years;
• BMI between 18 and 30 kg/m2;
• All subjects should use some form of contraception (for IUDs only Mirena is accepted)
• All subjects should be right-handed.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device (with the exception of the Mirena IUD), metal braces, facial tattoos and/or other metal objects;
• History of major head trauma or head/brain surgery;
• History of claustrophobia;
• History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
• Use of regular medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study;
• Pregnancy, lactation, wish to become pregnant;
• High alcohol consumption (\>15 alcoholic units consumed per week);
• Using drugs of abuse;
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study;
• Participants unable to provide informed consent
• Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
• Current smokers or current use of nicotine in any other way (including E-cigarettes and patches)
• History of clinical anxiety or depression, or a hospital anxiety or depression score \>8
• Participants whom score 8 or more on the HADS-questionnaire at study commencement

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht university

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• D. Keszthelyi

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not know the randomization order before starting the fMRI
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a randomized controlled fMRI study. Subjects will receive two types of stimulation (i.e. taVNS vs sham) during a single scanning visit. The order of stimulation applied during each visit is randomised. Infusion of capsaicin via a nasoduodenal tube will be used as co-intervention.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: October 26, 2024
• Study Start: April 17, 2023
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)