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NCT Number: NCT07290816

Effect of Non-invasive Neuromodulation on the Quality of Intestinal Cleansing

To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction.

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Key information

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 78 years of age, male or female;
  • Intended to undergo diagnostic, screening, or surveillance colonoscopy;
  • Signed written informed consent.

Exclusion criteria

  • Severe cardiac, cerebral, pulmonary, or renal complications or a history of acute cardiac infarction within six months;
  • High risk factors for bowel preparation such as history of colon surgery, BMI ≥ 28, inflammatory bowel disease, constipation (less than 3 bowel movements in the last week, and with straining to defecate, with hard stools and small amount of stools) or bowel obstruction;
  • High suspicion of colorectal cancer by auxiliary examination or early warning signs and symptoms of colorectal cancer: blood in stool, black stool, unexplained anemia, significant weight loss, abdominal mass and positive rectal fingerprinting;
  • The presence of surgical incisions or scars in the area where the electrostimulation treatment tablets are pasted, or near the ST36 acupoints on both legs;
  • Are participating in other clinical observation trials or have participated in other clinical trials within 30 days.

Treatment and study plan

Intestinal pacing + ST36 acupoint stimulation

Other

The day before the examination began a real stimulation treatment, namely, intestinal pacing (① location: positive pole placed on the navel (the line between the raphe and navel) 1 to 2 cm, the negative pole in the raphe and the navel line at the midpoint of the right 4 to 10 cm; ② parameters: the intestinal frequency: 2.4-3.7 cpm, the first time the frequency of use of 3.0 cpm, treatment of the base wave intensity of 0-15 gears, the first time to use the intestinal treatment intensity of 10 gears) , acupoint stimulation (① location: treatment sheet attached to both legs ST36 acupoints, i.e., four transverse fingers below the eye of the outer knee, 4 transverse fingers next to the tibia; ② parameters: the first use of acupoint intensity 30%, to the patient's self-conscious stimulation points have a slight pinprick sensation, lifting sensation, warm sensation is appropriate).

Sham acupoint intestinal pacing + sham ST36 acupoint stimulation

Other

A sham stimulation treatment was started one day before the examination, i.e., intestinal pacing treatment with the electrode pads offset to the lumbar side to stimulate the sham acupoints, and acupoint stimulation with the treatment pads applied to the ST36 acupoints but without turning on the current switch.

Primary outcomes

  1. Bowel Preparedness Score

    Time frame: Day 2

    Using the Boston Bowel Preparation Scale(BBPS)

Secondary outcomes

  1. Polyp detection rate

    Time frame: Day 2

  2. Adenoma detection rate

    Time frame: Day 2

  3. Adverse reactions

    Time frame: Baseline and Day 2

    collected using a questionnaire

  4. Complete Blood Count

    Time frame: Baseline and Day 2

  5. C-Reactive Protein

    Time frame: Baseline and Day 2

  6. Inflammatory Cytokines(TNF-α,IL-6,IL-10……)

    Time frame: Baseline and Day 2

  7. Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……)

    Time frame: Baseline and Day 2

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

Effect of Non-invasive Neuromodulation on the Quality of Bowel Cleansing: a Randomized, Controlled, Double-blind Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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