NCT05392439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

May 21, 2022

Last Update Submit

May 25, 2022

Conditions

Constipation-predominant Irritable Bowel SyndromeAbdominal Pain

Outcome Measures

Primary Outcomes (1)

  • Change in аbdominal pain between sham and active taVNS

    Weekly average of daily patient-assessed abdominal pain using the visual analog scale (VAS). VAS ranges from 0 to 10, with 0 indicating no abdominal pain and 10 indicating the maximal pain. Efficacy is evaluated as an improvement of ≥ 30%.

    4 weeks

Secondary Outcomes (6)

  • Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS

    4 weeks

  • Change in IBS quality of life (IBS-QOL) between sham and active taVNS

    4 weeks

  • Change in Bristol stool form scale (BSFS) between sham and active taVNS

    4 weeks

  • Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS

    4 weeks

  • Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS

    4 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Change in autonomic function assessed by the spectral parameters of heart rate variability between sham and active stimulation

    4 weeks

Study Arms (2)

taVNS treatment

EXPERIMENTAL

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).

Device: taVNS

sham-taVNS treatment

SHAM COMPARATOR

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

Device: sham-taVNS

Interventions

taVNSDEVICE

transcutaneous auricular vagal nerve stimulation

taVNS treatment
sham-taVNSDEVICE

transcutaneous stimulation at the elbow area

sham-taVNS treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, 200120, China

Location

Related Publications (1)

  • 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.

    PMID: 34138761RESULT

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Physician

Study Record Dates

First Submitted

May 21, 2022

First Posted

May 26, 2022

Study Start

March 1, 2020

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

CN(1)