SclerodermaNCT06646913
TENS in Scleroderma
A study testing Transcutaneous Electrical Nerve Stimulation in people with Scleroderma and Gastroparesis, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Gastroparesis, Systemic Sclerosis (SSc)
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
- Age \>= 18 years
- English speaking.
- Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
- Stable GI specific therapy including prokinetics over the last 4 weeks.
Who cannot join
- Pregnancy, or currently lactating.
- A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
- Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
- Known allergy to adhesive ECG electrodes.
- Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Nerve Stimulation in Scleroderma
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is:
To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.
Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.
- Conditions
- Scleroderma, Gastroparesis, Systemic Sclerosis (SSc)
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- TENS, Scleroderma, Gastroparesis, Pilot Study, Systemic Sclerosis
- Medical subject headings
- Scleroderma, Diffuse, Gastroparesis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Scleroderma Patients with Gastroparesis Symptoms | Experimental | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the TENS Device
Acceptability of the TENS device as demonstrated by:
- Subjects who are able to complete the trial by reaching the end of the testing period with the device
- Subjects who utilize the device for at least 80% of the proposed applications.
Measured: 4 weeks
Secondary outcomes (4)
Efficacy of TENS in Treating Scleroderma-related Gastroparesis
Mean change in the GCSI Total score (0-4 where higher score reflects greater severity)from baseline to after the TENS intervention.
Measured: 4 weeks
Assessment of the Effect of TENS of Gastroparesis Symptoms
Mean change in the ULCA-GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lowest severity and 3.0 is greatest severity) from baseline to after the TENS intervention.
Measured: 4 weeks
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. The CTCAE v5.0 is a standardize tool to grade adverse events on a scale of 1 to 5, where 1 is "mild" grade 2 is "moderate", 3 is "severe", 4 is "life threatening", and 5 is "death".
Outcome is shown as number of participants who experienced an adverse event in each possible grade.
Measured: 8 weeks
Gastric Motility in Participants
Participants were categorized as having "normal" or "abnormal" gastric motility at baseline. Those who were categorized as "abnormal" at baseline repeated the test at 4 weeks, after the intervention. Those who were classified as "normal" did not repeat the test.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Oct 2024
- Primary completion2 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Khanna, MD, MS, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646913
- Sponsor's protocol ID
- HUM00246152
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2024
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
PubMed 19558608Khanna D, Hays RD, Maranian P, Seibold JR, Impens A, Mayes MD, Clements PJ, Getzug T, Fathi N, Bechtel A, Furst DE. Reliability and validity of the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Arthritis Rheum. 2009 Sep 15;61(9):1257-63. doi: 10.1002/art.24730.
PubMed 19714600McMahan ZH, Kulkarni S, Chen J, Chen JZ, Xavier RJ, Pasricha PJ, Khanna D. Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management. Nat Rev Rheumatol. 2023 Mar;19(3):166-181. doi: 10.1038/s41584-022-00900-6. Epub 2023 Feb 6.
PubMed 36747090Song G, Trujillo S, Fu Y, Shibi F, Chen J, Fass R. Transcutaneous electrical stimulation for gastrointestinal motility disorders. Neurogastroenterol Motil. 2023 Nov;35(11):e14618. doi: 10.1111/nmo.14618. Epub 2023 Jun 8.
PubMed 37288650
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation in Scleroderma
- ClinicalTrials.gov ID
- NCT06646913
- Acronym / sponsor ID
- HUM00246152
- Conditions
- Scleroderma, Gastroparesis, Systemic Sclerosis (SSc)
- Keywords
- TENS, Scleroderma, Gastroparesis, Pilot Study, Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is:
To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.
Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scleroderma Patients with Gastroparesis Symptoms | Experimental | Device: Transcutaneous Electrical Nerve Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
- Age \>= 18 years
- English speaking.
- Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
- Stable GI specific therapy including prokinetics over the last 4 weeks.
Key exclusion criteria (5 listed)
- Pregnancy, or currently lactating.
- A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
- Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
- Known allergy to adhesive ECG electrodes.
- Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENSPatients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period. | Device | Scleroderma Patients with Gastroparesis Symptoms |
Primary outcome
Acceptability of the TENS Device
Time frame: 4 weeks
Acceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications.
4 secondary outcomes
Efficacy of TENS in Treating Scleroderma-related Gastroparesis
Time frame: 4 weeks
Assessment of the Effect of TENS of Gastroparesis Symptoms
Time frame: 4 weeks
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Time frame: 8 weeks
Gastric Motility in Participants
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19558608Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
- Background: PubMed 19714600Khanna D, Hays RD, Maranian P, Seibold JR, Impens A, Mayes MD, Clements PJ, Getzug T, Fathi N, Bechtel A, Furst DE. Reliability and validity of the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Arthritis Rheum. 2009 Sep 15;61(9):1257-63. doi: 10.1002/art.24730.
- Background: PubMed 36747090McMahan ZH, Kulkarni S, Chen J, Chen JZ, Xavier RJ, Pasricha PJ, Khanna D. Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management. Nat Rev Rheumatol. 2023 Mar;19(3):166-181. doi: 10.1038/s41584-022-00900-6. Epub 2023 Feb 6.
- Background: PubMed 37288650Song G, Trujillo S, Fu Y, Shibi F, Chen J, Fass R. Transcutaneous electrical stimulation for gastrointestinal motility disorders. Neurogastroenterol Motil. 2023 Nov;35(11):e14618. doi: 10.1111/nmo.14618. Epub 2023 Jun 8.
- Individual participant dataSharing planned: No
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Scleroderma and Gastroparesis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the TENS Device (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06646913, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.