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Updated: Jul 13, 2025
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation taVNS: Technique, Targeting, and Considerations
Published on: January 7, 2019
Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: a
Benjamin Sahn1,2, Kristine Pascuma3, Nina Kohn4,5
1Division of Pediatric Gastroenterology, Liver Diseases, & Nutrition, Steven & Alexandra Cohen Children's Medical Center, Northwell Health, 1991 Marcus Ave, Suite M100, New Hyde Park, NY, 11042, USA. bsahn@northwell.edu.
Insights
Transcutaneous auricular vagus nerve stimulation (ta-VNS) shows promise for pediatric inflammatory bowel disease. This noninvasive approach reduced symptoms and inflammatory markers in children with Crohn's disease and ulcerative colitis.
Area of Science:
- Gastroenterology
- Neurology
- Immunology
Background:
- Vagus nerve stimulation (VNS) is an emerging anti-inflammatory therapy targeting the nervous system to modulate immune activity.
- This study investigated the efficacy and safety of transcutaneous auricular VNS (ta-VNS) in pediatric patients diagnosed with Crohn's disease (CD) or ulcerative colitis (UC).
Purpose of the Study:
- To evaluate the effectiveness of ta-VNS in achieving clinical remission and reducing inflammatory markers in pediatric patients with mild to moderate CD or UC.
- To assess the safety profile of ta-VNS in this patient population.
Main Methods:
- Participants aged 10-21 years with mild/moderate CD or UC and elevated fecal calprotectin (FC > 200 ug/g) were enrolled.
- Subjects underwent a 2-week randomized crossover trial of daily ta-VNS or sham stimulation, followed by 14 weeks of twice-daily ta-VNS.
- Primary endpoints included clinical remission and a ≥50% reduction in FC from baseline to week 16. Heart rate variability and patient-reported outcomes were also monitored.
Main Results:
- Twenty-two subjects (10 CD, 12 UC) were analyzed, with baseline disease activity ranging from mild to moderate.
- At week 16, clinical remission was achieved in 50% of CD patients and 33% of UC patients with active symptoms at baseline.
- Among patients with elevated baseline FC (≥200 ug/g), 64.7% achieved a ≥50% reduction by week 16. Significant FC reduction was observed in UC (81%) and CD (51%) patients.
- No safety concerns were reported during the study.
Conclusions:
- Noninvasive ta-VNS demonstrated an ability to attenuate signs and symptoms in a pediatric cohort experiencing mild to moderate inflammatory bowel disease.
- The findings suggest ta-VNS is a safe and potentially effective therapeutic option for pediatric IBD.
Background:
Vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. This study evaluated the efficacy and safety of transcutaneous auricular VNS (ta-VNS) in patients with pediatric-onset Crohn's disease (CD) or ulcerative colitis (UC).
Methods:
Participants were 10-21 years of age with mild/moderate CD or UC and fecal calprotectin (FC) > 200 ug/g within 4 weeks of study entry. Subjects were randomized to receive either ta-VNS targeting the cymba conchae of the external left ear, or sham stimulation, of 5 min duration once daily for a 2-week period, followed by a cross over to the alternative stimulation for an additional 2 weeks. At week 4, all subjects received ta-VNS of 5 min duration twice daily until week 16. Primary study endpoints were clinical remission, and a ≥ 50% reduction in FC level from baseline to week 16. Heart rate variability measurements and patient-reported outcome questionnaires were completed during interval and week 16 assessments.
Results:
Twenty-two subjects were enrolled and analyzed (10 CD, 12 UC). Six of 10 with CD had a wPCDAI > 12.5 and 6/12 with UC had a PUCAI > 10 at baseline, correlating to mild to moderate symptom activity. Among the 12 subjects with active symptomatic disease indices at baseline, clinical remission was achieved in 3/6 (50%) with CD and 2/6 (33%) with UC at week 16. Despite all subjects having FC levels ≥ 200 within 4 weeks of enrollment, five subjects (4 UC, 1 CD) had FC levels < 200 at the baseline visit and were excluded from the FC analysis. Of the remaining 17, median baseline FC was 907 µg/g (IQR 411-2,120). At week 16, 11/17 (64.7%) of those with baseline FC ≥ 200 had a ≥ 50% reduction in FC (95% CI 38.3-85.8). In the UC subjects, there was an 81% median reduction in FC vs baseline (833 µg/g; p = 0.03) while in the CD subjects, median reduction in FC at 16 weeks was 51% (357 µg/g; p = 0.09). There were no safety concerns.
Conclusion:
Noninvasive ta-VNS attenuated signs and symptoms in a pediatric cohort with mild to moderate inflammatory bowel disease.
Trial Registration:
NCT03863704-Date of registration 3/4/2019.
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