Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders (TEA)

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis
• Intervention / Treatment: Device: Transcutaneous Electroacupuncture; Device: Sham TEA

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pankaj Pasricha, MD; Phone Number: 4105501793; Email: pasricha@jhu.edu
• Study Contact Backup: Name: Guillermo Barahona, MD; Phone Number: 4105508871; Email: gbaraho1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Contact: Pankaj J Pasricha, MD; Phone Number: 410-550-1793; Email: pasricha@jhu.edu
      • Contact: Guillermo Barahona; Phone Number: 4105508871; Email: gbaraho1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria for FD patients

• 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.

Inclusion criteria for chronic constipation patients

• 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.

Inclusion criteria for gastroparesis patients

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEA at ST36 and PC6 first and then sham TEA; 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; Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.; Device: Sham TEA; Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
Experimental: Sham-TEA and then TEA ST36 and PC6; 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; Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.; Device: Sham TEA; Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Weekly, up to 10 weeks
Change in number of Spontaneous Complete Bowel Movements	The effect of TEA on gastrointestinal dysmotility syndrome by changes in the number of Spontaneous Complete Bowel Movements.	Weekly, up to 10 weeks
Change in the Patient Assessment of Constipation (PAC-SYN) score	The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of Patient Assessment of Constipation (PAC-SYN). This questionnaire asks about constipation in the past 2 weeks. Symptoms include: abdominal discomfort, abdominal pain, bloating, stomach cramps, painful bowel movements, rectal burning, rectal bleeding, incomplete bowel movement, hardness of stool, size of bowel movements, straining and feeling to pass a bowel without success. Each symptom will be scored between 1 to 4 being 1 for mild symptoms; 2 for moderate; 3 for severe and 4 for very severe.	Every 2 weeks, up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale	The effect of TEA on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QoL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).	Every 2 weeks, up to 10 weeks
Change in Quality of Life as assessed by the Short Form (SF-36v2) Health Survey	The effect of TEA on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, week 4, week 6 and week 10
Change in electrogastrogram gastric slow waves	The effect of TEA on gastric rhythm by changes in electrogastrogram gastric slow waves in cycles/minute. The normal frequency of the gastric rhythm is around 3 cycles/minute.	Baseline, week 4, week 6 and week 10
Change in the R - R interval (seconds)	The effect of TEA on the electrical activity of the heart by changes in the R - R interval. The normal range of the R - R interval is: 0.6-1.2 seconds.	Baseline, week 4, week 6 and week 10

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: IRB00247402

Drug and device information, study documents

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