Clinical trial NCT03294616: Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
Official title: Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Gastroparesis
Keywords: transcutaneous electroacupuncture
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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 .


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 1 day
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 28 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 42 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 70 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 1 day
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 28 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 42 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 70 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 1 day
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 28 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 42 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 70 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 1 day
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 28 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 42 days
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
timeFrame: 70 days
Secondary outcomes:
measure: effects of TEA on gastric motility
timeFrame: 1 week
measure: effects of TEA on gastric motility
timeFrame: 2 weeks
measure: effects of TEA on gastric motility
timeFrame: 3 weeks
measure: effects of TEA on gastric motility
timeFrame: 4 weeks
measure: effects of TEA on autonomic function
timeFrame: 1 week
measure: effects of TEA on autonomic function
timeFrame: 2 weeks
measure: effects of TEA on autonomic function
timeFrame: 3 weeks
measure: effects of TEA on autonomic function
timeFrame: 4 weeks
measure: effects of TEA on gastric motility
timeFrame: 1 day
measure: effects of TEA on gastric motility
timeFrame: 28 days
measure: effects of TEA on gastric motility
timeFrame: 42 days
measure: effects of TEA on gastric motility
timeFrame: 70 days
measure: effects of TEA on gastric motility
timeFrame: 1 day
measure: effects of TEA on gastric motility
timeFrame: 28 days
measure: effects of TEA on gastric motility
timeFrame: 42 days
measure: effects of TEA on gastric motility
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on autonomic function
timeFrame: 1 day
measure: effects of TEA on autonomic function
timeFrame: 28 days
measure: effects of TEA on autonomic function
timeFrame: 42 days
measure: effects of TEA on autonomic function
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: day 1
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: day 1
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 1 day
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 28 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 42 days
measure: effects of TEA on GI hormones and inflammatory cytokine
timeFrame: 70 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jiande Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: