Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

Not Applicable

Terminated

• Conditions: Chronic Constipation
• Interventions: Device: taVNS; Drug: Laxative Agent

• Registration Number: NCT05723731
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-13
• Primary Completion: 2023-07-31
• Study Completion: 2023-09-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
2. Complete spontaneous bowel movements (CSBMs) per week < 3;
3. No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.

Exclusion Criteria

1. Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
2. Have a cardiac pacemaker implantation or other electronically implanted devices;
3. Prior taVNS treatment;
4. History of colorectal surgery, except for simple appendectomy;
5. Severe cardiovascular, hepatic, or renal disease;
6. Known malignancy;
7. Secondary constipation caused by medications and other diseases;
8. Pregnant or lactating women;
9. Refusal to sign an informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Laxative Agent	patients will receive taVNS at left tragus for four weeks.
Sham-treatment group	taVNS	patients will receive sham-taVNS at left earlobe for four weeks.
Sham-treatment group	Laxative Agent	patients will receive sham-taVNS at left earlobe for four weeks.
Treatment group	taVNS	patients will receive taVNS at left tragus for four weeks.

Primary Outcome Measures

Name	Time	Method
Responder rate	4 weeks	Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Responder rate at the time of the follow-up visit	8 weeks	Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks
Adverse events	12 weeks	Adverse events
Bristol stool form scale (BFSF)	12 weeks	Changes from baseline by time point in the BFSF
Patient Assessment of Constipation symptom (PAC-SYM)	12 weeks	Changes from baseline by time point in the PAC-SYM score
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)	12 weeks	Changes from baseline by time point in the PAC-QOL score
CSBMs	12 weeks	Changes from baseline by time point in the CSBMs
Self-Rating Depression Scale (SDS)	12 weeks	Changes from baseline by time point in SDS scores
Self-Rating Anxiety Scale (SAS)	12 weeks	Changes from baseline by time point in SAS scores
Spontaneous bowel movements (SBMs)	12 weeks	Changes from baseline by time point in the SBMs
Abdominal symptoms	12 weeks	Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping).
Laxative agents using	12 weeks	Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week

Trial Locations

Locations (5)

Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Xijing 986 Hospita; 🇨🇳 Xi'an, Shaanxi, China

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China

Department of Gastroenterology, National Clinical Research Center of Infectious Disease, The Third People's Hospital of Shenzhen, The Second Affiliated Hospital of Southern University of Science and Technology; 🇨🇳 Shenzhen, Guangdong, China

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China