Constipation-predominant Irritable Bowel SyndromeNCT05392439
Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome
A study testing taVNS in people with Constipation-predominant Irritable Bowel Syndrome and Abdominal Pain, run by Tongji University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome, Abdominal Pain
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willing to sign a written informed consent form
- met the Rome IV diagnostic criteria for IBS-C
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, 200120
About this study
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
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.
Read the 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.
- Being tested
- taVNS, sham-taVNS
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
transcutaneous auricular vagal nerve stimulation
sham-taVNSDevice
transcutaneous stimulation at the elbow area
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: sham-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 4 weeks
Secondary outcomes (6)
Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS
Questionnaire consists of 5 questions (abdominal pain intensity, abdominal pain frequency, abdominal distension degree, defecation satisfaction, and interference with quality of life), with a total score of 500 points and a higher score indicating a worse condition. Scores < 175 represent mild IBS symptoms, scores 175-300 represent moderate severity, and scores > 300 represent severe IBS.
Measured: 4 weeks
Change in IBS quality of life (IBS-QOL) between sham and active taVNS
Questionnaire is composed of 8 dimensions (dysphoria, interference with activity, body image, health concerns, food avoidance, social reaction, sex, and relationships), with 34 items assessing the degree to which IBS interferes with the patient's quality of life. Each item is evaluated on a 5-point Likert scale. The total score ranges from 34 to 170 and higher scores indicate better quality of life.
Measured: 4 weeks
Change in Bristol stool form scale (BSFS) between sham and active taVNS
The scale has 7 points according to stool type, from the hardest (1) to the softest (7). The lower the score, the more severe is constipation.
Measured: 4 weeks
Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS
SAS questionnaire has 20 items to assess physical and psychological symptoms, using a 4-point Likert scale ranging from 1 (none, or a little of the time) to 4 (most, or all of the time), with a total score ranging from 20 to 80. SAS scores below 50 indicate no anxiety, from 50 to 59 - mild anxiety, from 60 to 69 - moderate anxiety, 70 and above - severe anxiety.
Measured: 4 weeks
Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS
SDS questionnaire has 20 items to assess physical and psychological symptoms, using a 4-point Likert scale ranging from 1 (none, or a little of the time) to 4 (most, or all of the time), with a total score ranging from 20 to 80. SDS scores below 50 indicate no depression, from 50 to 59 - mild depression, from 60 to 69 - moderate depression, 70 and above - severe depression.
Measured: 4 weeks
Change in complete spontaneous bowel movements per week between sham and active taVNS
Number of bowel movements that occur without use of any medication or other methods to assist defecation and with a feeling of complete evacuation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Mar 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai East Hospital
- Responsible party
- Principal investigator, Xiaodan Shi, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392439
- Sponsor's protocol ID
- 2020-006
- Status last verified
- May 2022
- First submitted
- 21 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34138761
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05392439
- Acronym / sponsor ID
- 2020-006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Collaborators
- Shanghai East Hospital
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS treatment | Experimental | Device: taVNSThe 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). |
| sham-taVNS treatment | Sham comparator | Device: sham-taVNSSham-taVNS is performed with the same parameters as taVNS except that electrical stimulation is applied at the elbow area. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willing to sign a written informed consent form
- met the Rome IV diagnostic criteria for IBS-C
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNStranscutaneous auricular vagal nerve stimulation | Device | taVNS treatment |
| sham-taVNStranscutaneous stimulation at the elbow area | Device | sham-taVNS treatment |
Primary outcome
Change in аbdominal pain between sham and active taVNS
Time frame: 4 weeks
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%.
6 secondary outcomes
Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS
Time frame: 4 weeks
Change in IBS quality of life (IBS-QOL) between sham and active taVNS
Time frame: 4 weeks
Change in Bristol stool form scale (BSFS) between sham and active taVNS
Time frame: 4 weeks
Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS
Time frame: 4 weeks
Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS
Time frame: 4 weeks
Change in complete spontaneous bowel movements per week between sham and active taVNS
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Results publication: PubMed 34138761Shi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Constipation-predominant Irritable Bowel Syndrome and Abdominal Pain, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in аbdominal pain between sham and active taVNS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.