Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Device: transcutaneous electrical acustimulation at treatment sites; Device: transcutaneous electrical acustimulation at sham sites

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Wan; Phone Number: +8615529202305; Email: 408127528@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Jian Wan; Phone Number: +8615529202305; Email: 408127528@qq.com
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Tangdu Hospital
      • Contact: Ning Wang
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Honghui hospital
      • Contact: Shuang Han
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Second Affiliated Hospital of Xi 'an Jiaotong University
      • Contact: Sumei Sha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years
2. Ulcerative colitis diagnosed for at least 3 mouths.
3. Mayo score 4-10, Mayo endoscopic score 2-3 points
4. Resistant to at least one type of medical treatments

Exclusion Criteria:

1. Treatment-naive ulcerative colitis (no previous treatment)
2. Acute severe ulcerative colitis
3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis
4. Other systemic diseases
5. Pregnancy and lactation
6. Allergic to the electrode patch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Subjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks.	Device: transcutaneous electrical acustimulation at treatment sites; A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the treatment site. The precise stimulating sites are not described upon registration to reduce unblinding risk.; Other Names: TEA
Placebo Comparator: shame group; Subjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks.	Device: transcutaneous electrical acustimulation at sham sites; A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the sham treatment sites. The precise stimulating sites are not described upon registration to reduce unblinding risk.; Other Names: sham-TEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Mayo score	Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome.	8 weeks
Endoscopic remission	defined as Mayo endoscopic score ≤ 1	8 weeks
Clinical remission	overall score ≤2 [and no individual subscore >1]	8 weeks
Symptomatic remission	Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0	2, 4, 6, and 8 weeks
Fecal calprotectin	fecal sample	4 and 8 weeks
erythrocyte sedimentation rate	blood sample	4 and 8 weeks
C reactive protein	blood sample	4 and 8 weeks
pancreatic polypeptide	blood sample	4 and 8 weeks
norepinephrine	blood sample	4 and 8 weeks
acetyl choline	blood sample	4 and 8 weeks
acetyl choline	Intestinal mucosal tissue sample	8 weeks
alpha7 nicotinic acetylcholine receptor	Intestinal mucosal tissue sample	8 weeks
Inflammatory Bowel Disease Questionnaire Score	The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome	4 and 8 weeks
Hospital Anxiety and Depression scale score	anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome.	4 and 8 weeks
Pittsburgh sleep quality index	The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome.	4 and 8 weeks
autonomic profile characteristics	heart rate variability indicating sympathetic and parasympathetic activity	4 and 8 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Kaichun Wu, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: KY20232371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No