Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723731
• Other study ID #: KY20222075-F-1
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan, M.D
• Phone: 13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: February 28, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Device:
• taVNS
Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)

Drug:
• Laxative Agent
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University	Lanzhou	Gansu
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	Tangdu Hospital	Xi'an	Shaanxi
China	Xijing 986 Hospita	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010. — View Citation

Nag A, Martin SA, Mladsi D, Olayinka-Amao O, Purser M, Vekaria RM. The Humanistic and Economic Burden of Chronic Idiopathic Constipation in the USA: A Systematic Literature Review. Clin Exp Gastroenterol. 2020 Jul 16;13:255-265. doi: 10.2147/CEG.S239205. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate	Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks	4 weeks
Secondary	Responder rate at the time of the follow-up visit	Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks	8 weeks
Secondary	CSBMs	Changes from baseline by time point in the CSBMs	12 weeks
Secondary	Spontaneous bowel movements (SBMs)	Changes from baseline by time point in the SBMs	12 weeks
Secondary	Abdominal symptoms	Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping).	12 weeks
Secondary	Bristol stool form scale (BFSF)	Changes from baseline by time point in the BFSF	12 weeks
Secondary	Laxative agents using	Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week	12 weeks
Secondary	Patient Assessment of Constipation symptom (PAC-SYM)	Changes from baseline by time point in the PAC-SYM score	12 weeks
Secondary	Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)	Changes from baseline by time point in the PAC-QOL score	12 weeks
Secondary	Self-Rating Depression Scale (SDS)	Changes from baseline by time point in SDS scores	12 weeks
Secondary	Self-Rating Anxiety Scale (SAS)	Changes from baseline by time point in SAS scores	12 weeks
Secondary	Adverse events	Adverse events	12 weeks