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Not yet recruiting NCT07290816

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

No phase Interventional Intestinal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intestinal pacing + ST36 acupoint stimulation, Sham acupoint intestinal pacing + sham ST36 acupoint stimulation.
Who it may be relevant to
Registry conditions: Intestinal Polyps. Basic parameters: 18 years — 78 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Intestinal pacing + ST36 acupoint stimulation
    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 gea
  • Other Sham acupoint intestinal pacing + sham ST36 acupoint stimulation
    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 outcome measures

  • Bowel Preparedness Score [Time frame: Day 2]
Secondary outcome measures (7)
  • Polyp detection rate [Time frame: Day 2]
  • Adenoma detection rate [Time frame: Day 2]
  • Adverse reactions [Time frame: Baseline and Day 2]
  • Complete Blood Count [Time frame: Baseline and Day 2]
  • C-Reactive Protein [Time frame: Baseline and Day 2]
  • Inflammatory Cytokines(TNF-α，IL-6，IL-10……) [Time frame: Baseline and Day 2]
  • Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……) [Time frame: Baseline and Day 2]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT07290816 · 2023YS-077 Amendment 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗