Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C (TEA)

TEA for Study Participants With IBS-C Optimization of TEA Modalities for Treatment of IBS-C: A Phase 1 25 Study Participant Clinical Trial of Transcutaneous Electrical Acustimulation (TEA) in Study Participants With IBS-C

National Institutes of Health (NIH), Transtimulation Research, Inc, National Institute of Neurological Disorders and Stroke (NINDS)

This study aims to determine the most effective treatment with Transcutaneous Electrical Acustimulation (TEA) for Irritable Bowel Syndrome with Constipation (IBS-C) by comparing efficacy between 5 separate sessions. The rectum pressure as measured by a device called a barostat will be compared between visits. Each session will be testing a different combination of frequency and body position of the electrodes. Electrodes placed at either the wrist or knee will be stimulated at either 25 Hz or 100 Hz.

This study aims to discern whether Transcutaneous Electrical Acustimulation (TEA) at acupuncture points ST36 and/or PC6 will relieve the abdominal pain associated with IBS-C. Each study participant will have 5 research visits at the Michigan Medicine GI physiology lab. During these visits, they will undergo a procedure similar to Anal Rectal Manometry (ARM) performed by the GI physiology lab staff. TEA is similar to this procedure as it is uses the barostat device and is performed by the GI physiology lab staff. This device has a rubber catheter that will be inserted 5-15 cm into the rectum of the study participant. Then the GI physiology staff will inflate the catheter. They will ask the study participant when they can sense the catheter. Then the GI physiology staff will continue to inflate the catheter and the study participants feel discomfort (described as the 'urge to defecate'). Then the study participant will be asked to pass the balloon (like they would pass a bowel movement). The difference between ARM procedure and the study procedure is that there will be stimulation of acupuncture point ST36 which is below the knee cap or stimulation of acupuncture point PC6 which is just above the wrist. For this study, this mild electrical stimulation will occur simultaneously with the barostat procedure. At each visit there will be stimulation of only one of the points at either 100Hz or 25Hz. These are the potential combinations: ST36 100Hz, ST36-25Hz, PC6-100Hz, PC6-25Hz, Sham-TEA. The frequency and position combination (or sham visit) is randomly assigned. The randomization determines the order in which the study participant moves through the study. Every study participant will, in the end, complete one visit at each frequency and a sham visit. The study participant will also complete surveys at the appointment. The TEA device is classified by the FDA as a non-significant risk device.

All participants will receive all treatments including sham comparator in a randomized order. Subjects will not be informed of which treatment they will be receiving or the treatment order to which they are assigned.

All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart.

Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.

Change in pressure of maximum tolerance in mmHg of the rectum as measured by a barostat device when compared to pre-TEA administration.

The barostat device will measure the pressure changes in the rectum during controlled distension of the gastrointestinal organs. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham.

Pressure will be measured 6 times approximately 5 minutes apart during each visit. 5 visits will occur between 1 and 3 weeks apart.

Change in pressure of maximum tolerance in mmHg of the rectum as measured by a barostat device when compared to other modalities (body position, frequency and sham)

The barostat device will measure the pressure changes in the rectum during controlled distension of the gastrointestinal organs. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham.

Pressure will be measured 6 times approximately 5 minutes apart during each visit. 5 visits will occur between 1 and 3 weeks apart.

Change in pain as measured by Visual Analog Scale (VAS) surveys when compared to pre-TEA administration.

VAS surveys, a pain scale from 1(lowest) to 10 (highest), will be taken to assess efficacy of treatment on a 10 point scale.

VAS surveys will be taken 6 times approximately 5 minutes apart during each visit. 5 visits will occur between 1 and 3 weeks apart.

Change in pain as measured by Visual Analog Scale (VAS) surveys when compared to other modalities (body position, frequency and sham)

VAS surveys, a pain scale from 1(lowest) to 10 (highest), will be taken to assess efficacy of treatment on a 10 point scale.

VAS surveys will be taken 6 times approximately 5 minutes apart during each visit. 5 visits will occur between 1 and 3 weeks apart.

Inclusion Criteria: Willing to comply with all study procedures and be available for the duration of the study Diagnosed with IBS-C satisfying Rome IV criteria Have symptoms present for at least the last 3 months Have abdominal pain that is not adequately relieved at the time of screening and the time of randomization Has a VAS pain score of >3 (on 0-10 score) Exclusion Criteria: Have an unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes, unstable thyroid disease Have history of abdominal surgery (other than cholecystectomy or appendectomy) Are taking anticoagulants or antispasmodic, antidiarrheal, or opioids or other pain relief medications and cannot stop these medications for three consecutive days before each study visit Are pregnant or lactating; women of child bearing potential complete a pregnancy test at each visit Have known allergic reactions to components of the ECG electrodes Received treatment with an investigational drug or other intervention within 6 months of the date of consent Anything that, in the opinion of the investigator, would place the study participant at increased risk or preclude the study participant's full compliance with or completion of the study Are unable to provide informed consent

De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared

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