NCT04349891

Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders

Johns Hopkins University·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Gastroparesis
Drug/Device/Intervention
Transcutaneous Electroacupuncture
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Johns Hopkins University
Location
Baltimore, United States of America
Timeline & enrollment
Phase
N/A
Start date
Oct 01, 2020
End date
Oct 01, 2024
Enrollment
120 participants
Primary outcome

Change in the Gastroparesis Cardinal Symptom Index (GCSI) score,Change in number of Spontaneous Complete Bowel Movements,Change in the Patient Assessment of Constipation (PAC-SYN) score

Summary

Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional
 dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include
 abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension,
 bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders
 is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments
 in Eastern countries. The most commonly used acupuncture points (acupoints) for focused
 treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points.
 Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal
 motility in both animals and human.
 
 Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture
 (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles,
 similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but
 applied to acupoints. The investigators hypothesize that TEA as a new treatment option,
 improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility
 and therefore improves quality of life of the patients.
 
 The success of this project will lead to a noninvasive and convenient therapy for treating GI
 motility disorders. The proposed TEA method is expected to improve gastric and colonic
 functions and thus improve quality of life. In addition, the proposed TEA method and device
 are self-administrative after training during the first office visit. It provides a long-term
 treatment option for both FD, gastroparesis and chronic constipation.

ICD-10 classifications
Attention to gastrostomyGastrostomy statusOther gastritisGastritis, unspecifiedGastric diverticulum
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04349891
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT04349891 through Pure Global AI's free database. This phase not specified trial is sponsored by Johns Hopkins University and is currently Recruiting. The study focuses on Gastroparesis. Target enrollment is 120 participants.

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