Clinical trial NCT05392439: Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome
Official title: The Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain and Other Symptoms in Patients With Constipation-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation-predominant Irritable Bowel Syndrome
Abdominal Pain
Lead sponsor: Tongji University
Sponsor class: OTHER
Collaborators: name: Shanghai East Hospital
First posted: 2022-05-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.

Detailed description: This study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and receive taVNS or sham-taVNS treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each time for a period of 4 weeks. The taVNS and sham-taVNS treatment was applied using the commercially-available Transcutaneous Electrical Applicator device (Model SNM-FDC01, Ningbo MedKinetic Medical Device Co., Ltd.) with the skin electrodes placed bilaterally on auricular concha. The patients are requested to score the abdominal pain (using VAS) and complete BSFS, IBS-SSS, IBS-QOL, SAS, and SDS forms every week and fill out the bowel diary during taVNS or sham-taVNS. Emergency medications (Macrogol 4000 and pinaverium) are permitted for use when the patient cannot tolerate symptoms of constipation and abdominal pain.

Eligibility criteria: Inclusion Criteria:

1. willing to sign a written informed consent form
2. met the Rome IV diagnostic criteria for IBS-C

Exclusion Criteria:

1. history of previous abdominal surgery (other than appendectomy)
2. presence of carcinoma
3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
5. serious concomitant disease of the heart, liver, kidney, or diabetes
6. pregnancy or lactation
7. participating in another trial or enrolled in a trial during the past month
8. allergic reaction to surface electrodes

Primary outcomes:
measure: Change in аbdominal pain between sham and active taVNS
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS
timeFrame: 4 weeks
measure: Change in IBS quality of life (IBS-QOL) between sham and active taVNS
timeFrame: 4 weeks
measure: Change in Bristol stool form scale (BSFS) between sham and active taVNS
timeFrame: 4 weeks
measure: Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS
timeFrame: 4 weeks
measure: Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS
timeFrame: 4 weeks
measure: Change in complete spontaneous bowel movements per week between sham and active taVNS
timeFrame: 4 weeks
Other outcomes:
measure: Change in autonomic function assessed by the spectral parameters of heart rate variability between sham and active stimulation
timeFrame: 4 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
Study officials:
References:
citation: Shi X, Hu Y, Zhang B, Li W, Chen JD, Liu F. Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. JCI Insight. 2021 Jul 22;6(14):e150052. doi: 10.1172/jci.insight.150052.