SclerodermaNCT03294616

Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

A study testing transcutaneous electroacupuncture in people with Scleroderma and Gastroparesis, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Scleroderma, Gastroparesis
What is being tested?: transcutaneous electroacupuncture
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 6 Feb 2017to 20 Nov 2019
Phase: Interventional
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

No any systemic diseases;
no scleroderma; no history of gastrointestinal surgery;
no dyspeptic symptoms during the past 2 weeks;
not taking any medications except contraceptives during the past 2 weeks;
age 18 and older.

Who cannot join

History of any systemic diseases or surgeries;
allergic to adhesives; pregnancy;
unable to sign the consent form.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224

Other trials in United States

About this study

An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

Conditions: Scleroderma, Gastroparesis
Being tested: transcutaneous electroacupuncture
Keywords: transcutaneous electroacupuncture
Medical subject headings: Scleroderma, Diffuse, Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcutaneous electroacupunctureDevice
Also called TEA
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions

Study groups in NCT03294616
Study group	Role	What they receive
scleroderma patients-0	Experimental	for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial). Receives: Device: transcutaneous electroacupuncture
scleroderma patient-1	Experimental	for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used. Receives: Device: transcutaneous electroacupuncture
scleroderma patients-2	Experimental	for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used. Receives: Device: transcutaneous electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Measured: 1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Measured: 28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Measured: 42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
Measured: 70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Measured: 1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Measured: 28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Measured: 42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Measured: 70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Measured: 1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Measured: 28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Measured: 42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Measured: 70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
Measured: 1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
Measured: 28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
Measured: 42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
Measured: 70 days

Secondary outcomes (120)

effects of TEA on gastric motility
visit 1 in acute phase; gastric slow waves recording
Measured: 1 week
effects of TEA on gastric motility
visit 2 in acute phase; gastric slow waves recording
Measured: 2 weeks
effects of TEA on gastric motility
visit 3 in acute phase; gastric slow waves recording
Measured: 3 weeks
effects of TEA on gastric motility
visit 4 in acute phase; gastric slow waves recording
Measured: 4 weeks
effects of TEA on autonomic function
visit 1 in acute phase; heart rate variability recording
Measured: 1 week
effects of TEA on autonomic function
visit 2 in acute phase; heart rate variability recording
Measured: 2 weeks
effects of TEA on autonomic function
visit 3 in acute phase; heart rate variability recording
Measured: 3 weeks
effects of TEA on autonomic function
visit 4 in acute phase; heart rate variability recording
Measured: 4 weeks
effects of TEA on gastric motility
visit 1 in chronic phase; gastric slow waves recording
Measured: 1 day
effects of TEA on gastric motility
visit 2 in chronic phase; gastric slow waves recording
Measured: 28 days
effects of TEA on gastric motility
visit 3 in chronic phase; gastric slow waves recording
Measured: 42 days
effects of TEA on gastric motility
visit 4 in chronic phase; gastric slow waves recording
Measured: 70 days
effects of TEA on gastric motility
visit 1 in chronic phase; breath test will be used to assess gastric emptying
Measured: 1 day
effects of TEA on gastric motility
visit 2 in chronic phase; breath test will be used to assess gastric emptying
Measured: 28 days
effects of TEA on gastric motility
visit 3 in chronic phase; breath test will be used to assess gastric emptying
Measured: 42 days
effects of TEA on gastric motility
visit 4 in chronic phase; breath test will be used to assess gastric emptying
Measured: 70 days
effects of TEA on autonomic function
visit 1 in chronic phase; heart rate variability recording
Measured: 1 day
effects of TEA on autonomic function
visit 2 in chronic phase; heart rate variability recording
Measured: 28 days
effects of TEA on autonomic function
visit 3 in chronic phase; heart rate variability recording
Measured: 42 days
effects of TEA on autonomic function
visit 4 in chronic phase; heart rate variability recording
Measured: 70 days
effects of TEA on autonomic function
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Measured: 1 day
effects of TEA on autonomic function
visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Measured: 28 days
effects of TEA on autonomic function
visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Measured: 42 days
effects of TEA on autonomic function
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function
Measured: 70 days
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 1 day
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 28 days
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 42 days
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 70 days
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 1 day
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 28 days
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 42 days
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 70 days
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 1 day
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 28 days
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 42 days
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Measured: 70 days
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 1 day
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 28 days
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 42 days
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 70 days
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 1 day
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 28 days
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 42 days
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 70 days
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 1 day
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 28 days
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 42 days
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Measured: day 1
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Measured: day 1
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Measured: 70 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201720 Nov 2019

First posted27 Sep 2017
Study start6 Feb 2017
Primary completion30 Jun 2019
Study completion20 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SclerodermaStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe 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: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03294616
Sponsor's protocol ID: IRB00089514
Status last verified: Nov 2019
First submitted: 18 Aug 2017
Last updated: 26 Nov 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: haven't decided yet.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Scleroderma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
ClinicalTrials.gov ID: NCT03294616
Acronym / sponsor ID: IRB00089514
Conditions: Scleroderma, Gastroparesis
Keywords: transcutaneous electroacupuncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 6 Feb 2017 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 20 Nov 2019 (actual)
First posted: 27 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
scleroderma patients-0	Experimental	Device: transcutaneous electroacupuncturefor acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
scleroderma patient-1	Experimental	Device: transcutaneous electroacupuncturefor chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
scleroderma patients-2	Experimental	Device: transcutaneous electroacupuncturefor chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

No any systemic diseases;
no scleroderma; no history of gastrointestinal surgery;
no dyspeptic symptoms during the past 2 weeks;
not taking any medications except contraceptives during the past 2 weeks;
age 18 and older.

Key exclusion criteria (3 listed)

History of any systemic diseases or surgeries;
allergic to adhesives; pregnancy;
unable to sign the consent form.

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 electroacupunctureAlso: TEAWeak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions	Device	scleroderma patient-1, scleroderma patients-0, scleroderma patients-2

Primary outcome

effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 1 day
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 28 days
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 42 days
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 70 days
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 1 day
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 28 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 42 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 70 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 1 day
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 28 days
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 42 days
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 70 days
SF-36 questionnaire will be used to assess general quality of life
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 1 day
a validated method including 9 symptoms will be used to assess GI symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 28 days
a validated method including 9 symptoms will be used to assess GI symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 42 days
a validated method including 9 symptoms will be used to assess GI symptoms
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Time frame: 70 days
a validated method including 9 symptoms will be used to assess GI symptoms

120 secondary outcomes

effects of TEA on gastric motility
Time frame: 1 week
effects of TEA on gastric motility
Time frame: 2 weeks
effects of TEA on gastric motility
Time frame: 3 weeks
effects of TEA on gastric motility
Time frame: 4 weeks
effects of TEA on autonomic function
Time frame: 1 week
effects of TEA on autonomic function
Time frame: 2 weeks
effects of TEA on autonomic function
Time frame: 3 weeks
effects of TEA on autonomic function
Time frame: 4 weeks
effects of TEA on gastric motility
Time frame: 1 day
effects of TEA on gastric motility
Time frame: 28 days
effects of TEA on gastric motility
Time frame: 42 days
effects of TEA on gastric motility
Time frame: 70 days
effects of TEA on gastric motility
Time frame: 1 day
effects of TEA on gastric motility
Time frame: 28 days
effects of TEA on gastric motility
Time frame: 42 days
effects of TEA on gastric motility
Time frame: 70 days
effects of TEA on autonomic function
Time frame: 1 day
effects of TEA on autonomic function
Time frame: 28 days
effects of TEA on autonomic function
Time frame: 42 days
effects of TEA on autonomic function
Time frame: 70 days
effects of TEA on autonomic function
Time frame: 1 day
effects of TEA on autonomic function
Time frame: 28 days
effects of TEA on autonomic function
Time frame: 42 days
effects of TEA on autonomic function
Time frame: 70 days
effects of TEA on autonomic function
Time frame: 1 day
effects of TEA on autonomic function
Time frame: 28 days
effects of TEA on autonomic function
Time frame: 42 days
effects of TEA on autonomic function
Time frame: 70 days
effects of TEA on autonomic function
Time frame: 1 day
effects of TEA on autonomic function
Time frame: 28 days
effects of TEA on autonomic function
Time frame: 42 days
effects of TEA on autonomic function
Time frame: 70 days
effects of TEA on autonomic function
Time frame: 1 day
effects of TEA on autonomic function
Time frame: 28 days
effects of TEA on autonomic function
Time frame: 42 days
effects of TEA on autonomic function
Time frame: 70 days
effects of TEA on autonomic function
Time frame: 1 day
effects of TEA on autonomic function
Time frame: 28 days
effects of TEA on autonomic function
Time frame: 42 days
effects of TEA on autonomic function
Time frame: 70 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
Individual participant dataSharing planned: Undecided. haven't decided yet.

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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.

Jiande Chen, Ph.D principal investigator

Johns Hopkins University

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 electroacupuncture in people with Scleroderma and Gastroparesis, run by Johns Hopkins University 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 3 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 26 Nov 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

effect of TEA on symptoms in Systemic Sclerosis (SSc) patients (time frame: 1 day). The study lists 16 primary outcomes in all. 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 NCT03294616.

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 26 Nov 2019.