NCT05165108

Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of transcutaneous vagal stimulation in adult patients with active Crohn's disease.

Detailed description

Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) characterized by chronic inflammation in the digestive tract. The pathogenesis of IBD involves immunological, genetic and environmental factors. Currently there is no cure for Crohn's disease and available medical and surgical treatments are expensive and often associated with significant side effects. Anti-tumor necrosis factor alpha (anti-TNF-α) agents are widely used for treatment of Crohn's disease. Electrical neuromodulation is a new treatment approach of bioelectronic medicine, involving molecular medicine, neuroscience, and bioengineering. Multiple possible mechanisms have been proposed for electrical neuromodulation in GI diseases, including central, autonomic, and/or enteric mechanisms. Vagal tone is significantly blunted in IBD and is associated with high TNF- α levels. Animal and preliminary human studies have demonstrated that electrical vagal nerve stimulation (VNS), including non-invasive vagal stimulation (nVNS), exerts an anti-inflammatory effect by harnessing the cholinergic anti-inflammatory pathway. In healthy humans nVNS has been shown to decrease tumor necrosis factor-α levels. Invasive VNS has been shown to improve inflammation in preliminary studies in patients with Crohn's disease. Adult patients with active Crohn's disease will be asked to self-administer transcutaneous vagal nerve stimulation three times per day for 16 weeks. Inflammatory laboratory markers will be compared for each patient against their baseline levels to determine if the intervention helps reduce inflammation cause by their Crohn's disease. Questionnaires will be administered to evaluation their symptoms, and quality of life over the 16 week treatment period.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DEVICE	Vagal Nerve Stimulator	A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2021-12-21
• Last updated: 2025-03-06
• Results posted: 2025-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study