TEA for Constipation in Systemic Sclerosis

(TEA in SSc Trial)

Overseen By Sharvari R Kamat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Diarrhea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called transcutaneous electrical acustimulation (TEA) to determine its effectiveness for people with systemic sclerosis who experience constipation. Researchers aim to discover if TEA can enhance digestive function by influencing the body's nerves and reducing inflammation. The study includes two groups: one receiving the TEA treatment and the other receiving a sham version for comparison. Individuals with systemic sclerosis-related constipation and slow-moving digestion may be suitable candidates, particularly if they are not currently undergoing treatment or if their current treatment is ineffective. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you can participate if you are not on therapy for constipation or if you have been on stable therapy for constipation for at least one month before starting the trial.

What prior data suggests that transcutaneous electrical acustimulation (TEA) is safe for treating constipation in systemic sclerosis?

Research has shown that transcutaneous electrical acustimulation (TEA) is generally safe and well-tolerated by patients. In studies involving individuals with scleroderma, TEA helped alleviate constipation. Specifically, patients experienced noticeable improvements in their symptoms compared to those who received a placebo treatment. This suggests that TEA can be effective without causing serious side effects. One study found that TEA increased bowel movements from an average of 2 times a week to about 3.7 times a week, demonstrating its potential benefits.

While detailed information on side effects isn't always available, these findings suggest that TEA is safe for people. Anyone considering joining a clinical trial should discuss personal risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Acustimulation (TEA) for constipation in systemic sclerosis because it offers a unique, non-invasive way to potentially improve gut motility. Unlike standard treatments like laxatives or prokinetic drugs, which often come with side effects and variable effectiveness, TEA uses mild electrical impulses to stimulate the nerves that regulate bowel function. This innovative approach could lead to more consistent and natural relief from constipation, offering hope for those who struggle with current treatment options.

What evidence suggests that transcutaneous electrical acustimulation (TEA) is effective for constipation in systemic sclerosis?

This trial will compare Transcutaneous Electrical Acustimulation (TEA) with Sham-TEA for treating constipation in systemic sclerosis. Studies have shown that TEA can help relieve constipation. In one study, participants using TEA experienced more frequent bowel movements, increasing from about 2 to nearly 4 times a week, compared to those who received a fake treatment. This suggests that TEA can help the body manage constipation more effectively. Another study involving patients with scleroderma, a condition affecting the skin and organs, found that TEA applied to specific body points improved their digestive symptoms. TEA appears to enhance the function of the autonomic nervous system, which controls digestion and bowel movements. So far, research looks promising for using TEA to treat constipation in people with systemic sclerosis. ^{1 2 3 4 6}

Who Is on the Research Team?

Zsuzsanna H McMahan, MD, MHS (M-PI)

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for patients with systemic sclerosis (SSc) who are experiencing constipation. It's open to those not yet treated for constipation or those still having issues despite stable therapy for a month. Participants should have slow colonic transit or rectal hyposensitivity as defined in the study, but can't join if they have both diarrhea and constipation symptoms.

Inclusion Criteria

I have constipation and haven't started treatment or it hasn't improved with current treatment.

Patients with constipation related to systemic sclerosis from the first part of the study.

You still have a lot of the markers left in your colon 5 days after swallowing the capsule, or you have a condition called RH.

Exclusion Criteria

I experience both diarrhea and constipation, but mainly have diarrhea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous electrical acustimulation (TEA) to assess its effects on colonic and anorectal physiology

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham-TEA
• Transcutaneous Electrical Acustimulation (TEA)

Trial Overview The study tests whether transcutaneous electrical acustimulation (TEA), which involves using electrical currents on the skin, can improve bowel function and sensitivity by enhancing autonomic nervous system activity in SSc patients. The effects of TEA versus Sham-TEA (a pretend treatment) are compared.

How Is the Trial Designed?

Group I: Transcutaneous Electrical Acustimulation (TEA) Experimental Treatment 1 Intervention

Group II: Sham-TEA Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

Transcutaneous electrical acustimulation (TEA) significantly improved postoperative recovery in women after cesarean section, leading to faster gastrointestinal recovery, including reduced time to first flatus and defecation, and improved stool quality.

TEA enhanced vagal activity and reduced sympathetic activity, which are associated with better gastrointestinal function and lower pain levels, indicating its potential as an effective non-invasive treatment for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and Mechanisms of Transcutaneous Electrical Acustimulation on Postoperative Recovery After Elective Cesarean Section. Li, M., Xu, F., Liu, M., et al.[2022]

In a study involving 17 scleroderma patients, two weeks of daily transcutaneous electrical nerve stimulation (TENS) significantly improved gastric myoelectrical activity, indicating enhanced neurogastric functioning.

Prolonged TENS treatment also led to decreased levels of plasma VIP, motilin, and IL-6, which are associated with gastrointestinal function, and reduced symptoms like abdominal pain and bloating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged treatment with transcutaneous electrical nerve stimulation (TENS) modulates neuro-gastric motility and plasma levels of vasoactive intestinal peptide (VIP), motilin and interleukin-6 (IL-6) in systemic sclerosis. McNearney, TA., Sallam, HS., Hunnicutt, SE., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) applied at specific acupoints significantly improved symptoms of slow transit constipation (STC) in 39 patients, reducing dyschezia scores and promoting colonic transit over a 2-week treatment period.

The TENS treatment also led to significant reductions in anxiety and depression scores, indicating that it not only helps with constipation but may also improve overall mental well-being in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous electrical nerve stimulation improves oppilative symptoms and increases colonic transit in patients with slow transit constipation]. Shi, N., Liu, S., Xie, XP., et al.[2009]

Transcutaneous electrical acustimulation (TEA) significantly improved tolerance to motion sickness (MS) in healthy participants, with 22 out of 50 completing all five rotations compared to only 11 in the sham group, and it also prolonged the total tolerable rotation time (220.4 seconds vs 173.6 seconds).

TEA reduced MS symptoms and improved gastric function by enhancing vagal activity and suppressing the increase of stress-related hormones like arginine vasopressin and norepinephrine during motion stimulation, indicating its potential as an effective treatment for severe motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Ameliorates Motion Sickness Induced by Rotary Chair in Healthy Subjects: A Prospective Randomized Crossover Study. Zhao, Q., Ning, BF., Zhou, JY., et al.[2022]

Home transcutaneous electrical stimulation (TES) significantly improved bowel function in children with slow-transit constipation (STC), with 69% of patients experiencing increased defecation frequency and 50% showing reduced soiling after 3 to 6 months of self-administration.

The study involved 32 children, and results indicated that TES not only enhanced bowel movements but also improved stool consistency and reduced abdominal pain, highlighting its potential as an effective treatment option for STC when administered under clinician guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home transcutaneous electrical stimulation to treat children with slow-transit constipation. Yik, YI., Ismail, KA., Hutson, JM., et al.[2015]

In a pilot study involving 70 participants with severe chronic constipation, electroacupuncture (EA) was found to be more effective than transcutaneous electrical stimulation (TES) in increasing the number of complete spontaneous bowel movements (CSBMs) over an 8-week treatment period, with significant improvements observed during follow-up at weeks 20 and 32.

EA also led to a greater reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) scores compared to TES, indicating a better overall quality of life for participants receiving EA, although TES remains a noninvasive option for those hesitant about acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial. Zeng, Y., Chen, F.[2023]

In a study involving 11 patients with progressive systemic sclerosis (PSS), electrical acupuncture significantly reduced plasma endothelin-1 (ET-1) levels, suggesting a potential mechanism for improved blood flow and temperature in affected areas.

While electrical acupuncture decreased ET-1 levels in PSS patients, it had varying effects on patients with scleroderma spectrum disorders (SSD), indicating that the treatment's efficacy may differ based on the specific condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of electrical acupuncture-stimulation therapy using thermography and plasma endothelin (ET-1) levels in patients with progressive systemic sclerosis (PSS). Maeda, M., Kachi, H., Ichihashi, N., et al.[2019]

In a study involving 32 patients with systemic sclerosis (SSc), transcutaneous auricular vagal nerve stimulation (tVNS) significantly reduced pain levels by an average of 27.7%, while the active control only showed a 7.7% reduction, indicating tVNS's efficacy in pain management.

tVNS also led to a significant decrease in the inflammatory marker interleukin-6 compared to the active control, suggesting a potential mechanism for its pain-relieving effects, although it did not show significant improvements in overall quality of life or heart rate variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular branch vagal nerve stimulation as a non-invasive add-on therapeutic approach for pain in systemic sclerosis. Bellocchi, C., Carandina, A., Della Torre, A., et al.[2023]

In a study involving 17 scleroderma patients, transcutaneous electrical nerve stimulation (TENS) applied at gastrointestinal acupoints significantly improved GI symptoms and quality of life after 14 days of treatment.

TENS not only increased sympathetic and vagal activities acutely but also normalized the sympathovagal balance over time, leading to decreased GI symptom scores and improved physical functioning, indicating its potential as a treatment option for upper GI symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) improves upper GI symptoms and balances the sympathovagal activity in scleroderma patients. Sallam, H., McNearney, TA., Doshi, D., et al.[2022]

A self-administered finger stretching program significantly improved passive range of motion (ROM) in patients with systemic sclerosis (SSc) after just one month, with continued improvements or maintenance of ROM observed over a year.

The program also led to better hand function, as indicated by a significant decrease in the Health Assessment Questionnaire (HAQ) score, suggesting that stretching can enhance daily activities like eating and gripping for SSc patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of self-administered stretching for finger joint motion in Japanese patients with systemic sclerosis. Mugii, N., Hasegawa, M., Matsushita, T., et al.[2015]

Transcutaneous electrical acustimulation (TEA) at acupoint ST36 significantly increased the number of spontaneous bowel movements and improved constipation symptoms in 44 patients over a 2-week treatment period, with effects lasting for at least 4 weeks after treatment cessation.

TEA treatment enhanced rectal sensitivity and increased vagal activity, suggesting that these mechanisms may contribute to its efficacy in alleviating chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained ameliorating effects and autonomic mechanisms of transcutaneous electrical acustimulation at ST36 in patients with chronic constipation. Zhou, JY., Wang, J., Ning, BF., et al.[2022]

Transcutaneous electrical stimulation (TES) significantly improved symptoms of slow-transit constipation in a study of 28 women, with notable decreases in constipation severity and abdominal pain, as well as an increase in the frequency of bowel movements.

The treatment was applied for 20 minutes, three times a week over 4 weeks, and while both the treatment and control groups reported reduced abdominal pain, only the TES group showed a significant increase in evacuation frequency, highlighting its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving slow-transit constipation with transcutaneous electrical stimulation in women: A randomized, comparative study. Yang, Y., Yim, J., Choi, W., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9720110/

Sustained ameliorating effects and autonomic mechanisms ... TEA ameliorates constipation with sustained effects, which may be mediated via improvement of rectal sensitivity and enhancement of vagal activity.

2. withpower.com withpower.com/trial/phase-autonomic-nervous-system-diseases-7-2023-6dcf7

TEA for Constipation in Systemic Sclerosis (TEA in SSc Trial) In a study involving 17 scleroderma patients, transcutaneous electrical nerve stimulation (TENS) applied at gastrointestinal acupoints significantly improved GI ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03294616

Transcutaneous Electroacupuncture for Gastric ... effect of TEA on symptoms in Systemic Sclerosis (SSc) patients, Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms, 42 days.

4. journals.lww.com journals.lww.com/ctg/fulltext/2022/05000/transcutaneous_electrical_acustimulation_improves.12.aspx

Transcutaneous Electrical Acustimulation Improves... Chronic TEA increased spontaneous bowel movements (3.72 vs 2.00 per week with sham-TEA, P < 0.0001) and significantly reduced constipation symptoms and ...

5. trial.medpath.com trial.medpath.com/clinical-trial/82c7ba09c8de041a/nct05989763-pathophysiological-mechanisms-constipation-systemic-sclerosis

Interrogating the Pathophysiological Mechanisms of ... The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715921061742

Transcutaneous Electrical Acustimulation Ameliorates ... TEA improved the percentage of normal gastric slow waves, compared with sham-TEA (56.0 ± 2.1% vs 51.6 ± 2.0%, p = 0.033). TEA also significantly enhanced vagal ...