Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders

NCT04349891 | Terminated Results FDA Device

• 1 other identifier: IRB00247402
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human. Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients. The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score

  The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe). GCSI total score can range from 0 to 5, with higher scores reflecting greater symptom severity. The

  Up to 10 weeks

Secondary Outcomes (4)

• Change in Number of Spontaneous Complete Bowel Movements

  Up to 10 weeks

• Change in the Patient Assessment of Constipation (PAC-SYN) Score

  Up to 10 weeks

• Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale

  Up to 10 weeks

• Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey

  Up to 10 weeks

Study Arms (2)

TEA at ST36 and PC6 first and then sham TEA

EXPERIMENTAL

Patients in this group will be treated with TEA at ST36 and PC6 for 4 weeks, followed with a 2-week washout period and another 4-week period with sham TEA.

Device: Transcutaneous Electroacupuncture; Device: Sham TEA

Sham-TEA and then TEA ST36 and PC6

EXPERIMENTAL

Patients in this group will be treated with sham-TEA for 4 weeks, followed with a 2-week washout period and another 4-week period with TEA at ST36 and PC6.

Device: Transcutaneous Electroacupuncture; Device: Sham TEA

Interventions

Transcutaneous Electroacupuncture DEVICE

Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Sham-TEA and then TEA ST36 and PC6; TEA at ST36 and PC6 first and then sham TEA

Sham TEA DEVICE

Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Sham-TEA and then TEA ST36 and PC6; TEA at ST36 and PC6 first and then sham TEA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bothersome postprandial fullness
• Symptoms of early satiation, epigastric pain, epigastric burning during the last 3 months
• No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms.
• Males and females between ages 18-80 yrs;
• Subjects with high probability for compliance and completion of the study.
• Satisfying Rome IV criteria for diagnosis of functional constipation;
• abdominal X-ray or anorectal manometry test during the past 3 months indicating delayed colonic transit (more than 20% ingested markers are retained) or abnormal colonic motility;
• ages 18-80 years;
• no constipation medication for a minimum of 1 week before enrollment except for rescue agents (stimulant laxatives, such as bisacodyl);
• willing to comply with the treatment regimen.
• At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms);
• Abnormal gastric emptying diagnosed during the past year;
• Males and females between ages 18-80 yrs;
• Subjects with high probability for compliance and completion of the study.
• Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.

You may not qualify if:

• History of gastric bezoar or diverticulitis.
• Severe daily abdominal pain requiring narcotic medications.
• Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
• Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy;
• Surgery within the past 3 months.
• Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
• Those who have been treated with acupuncture or those who are familiar with acupuncture points.
• Anyone with an implantable cardiac pacemaker or defibrillator.
• unable to give informed consent;
• taking prokinetics, anticholinergic or dopaminergic agents;
• history of gastrointestinal surgery;
• pregnant or preparing to conceive a child;
• diabetes;
• allergic to skin preparation.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jay Pasricha
• Organization: Mayo Clinic Arizona

pasricha.jay@mayo.edu

(480)301-4279

Study Officials

• Pankaj Pasricha, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: October 1, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: September 19, 2024
• Results First Posted: November 24, 2023

Record last verified: 2024-09

Locations

US (1)