Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome

NCT ID: NCT05392439

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-12-15

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.

Conditions

Constipation-predominant Irritable Bowel Syndrome; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

taVNS treatment

The taVNS treatment is performed at auricular cymba concha. The stimulation parameters are set as follows: train on-time of 2 seconds and off-time of a 3-second pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude of 0-2 milliamp (at the maximum level tolerated by the subject).

Group Type: EXPERIMENTAL

taVNS

Intervention Type: DEVICE

transcutaneous auricular vagal nerve stimulation

sham-taVNS treatment

Sham-taVNS is performed with the same parameters as taVNS except that electrical stimulation is applied at the elbow area.

Group Type: SHAM_COMPARATOR

sham-taVNS

Intervention Type: DEVICE

transcutaneous stimulation at the elbow area

Interventions

taVNS

transcutaneous auricular vagal nerve stimulation

Intervention Type: DEVICE

sham-taVNS

transcutaneous stimulation at the elbow area

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Xiaodan Shi

Junior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 34138761 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-006

Identifier Type: -

Identifier Source: org_study_id