NCT06659172

Effects of tVNS on Visceral Pain

The Effect of Transcutaneous Vagal Nerve Stimulation on the Processing of Visceral Pain Signals: a High Resolution fMRI Study in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Abdominal pain is often caused by conditions like irritable bowel syndrome (IBS) and functional dyspepsia (FD), which are chronic and can fluctuate daily. IBS and FD affect about 6% and 10% of the general population, respectively. Many patients visiting gastroenterology clinics suffer from these conditions, and pain is the most challenging symptom to manage. Conventional treatments often don't provide lasting relief, affecting patients' quality of life and causing significant socio-economic impact. The underlying causes of IBS and FD are not well understood, making it difficult to develop effective treatments. These conditions are considered disorders of the gut-brain interaction, involving communication between the gut and brain via the vagus nerve. The vagus nerve sends sensory information from the gut to the brainstem, particularly the nucleus tractus solitarius (NTS), which then communicates with other brain areas involved in pain perception. The vagus nerve has a branch that innervates the external ear, making it accessible for non-invasive stimulation. Transcutaneous auricular vagal nerve stimulation (taVNS) has been used experimentally for conditions like migraines and fibromyalgia. A recent trial showed that daily taVNS can reduce abdominal pain in adolescents with functional abdominal pain and IBS. Additionally, studies using advanced brain imaging have shown that taVNS activates the NTS. However, it's unclear if this activation is responsible for the pain-relieving effects of taVNS. New neuroimaging techniques allow for detailed studies of gut-brain communication and the effects of taVNS. Understanding these mechanisms could help develop taVNS as a safe and effective treatment for abdominal pain. Preliminary Results: We developed a human pain model using capsaicin (a component of chili peppers) infused into the duodenum to simulate abdominal pain. This model reliably triggers pain and activates brain regions involved in pain perception, including the NTS. This model is useful for studying treatments like taVNS for visceral pain relief. Clinical Significance: taVNS is gaining attention as a treatment for various conditions, but its effects are not yet fully understood. This study aims to explore the neurobiological effects of taVNS on visceral pain using advanced imaging techniques. Establishing these effects is crucial for integrating taVNS into clinical practice. Vagus Nerve Stimulation (VNS): VNS was first used in 1988 to treat epilepsy with surgically implanted devices. Recently, non-invasive taVNS methods have been developed, targeting the auricular branch of the vagus nerve in the ear. taVNS is safe, well-tolerated, and user-friendly. Advanced Imaging: Using 7 Tesla MRI provides higher resolution imaging than standard 1.5 or 3 Tesla scanners, allowing for detailed brain studies. These scanners are becoming more common and are safe for research. In the Netherlands, several institutions use 7 Tesla scanners for patient research without reported adverse effects.

Conditions

• Healthy Females
• Vagus Nerve Stimulation
• Abdominal Pain

Interventions

Type	Name	Description
DEVICE	taVNS	transauricular vagus nerve stimulation

Timeline

• Start date: 2023-04-17
• Primary completion: 2025-01-03
• Completion: 2025-01-03
• First posted: 2024-10-26
• Last updated: 2025-02-17

Locations

1 site across 1 country: Netherlands