The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study

Not Applicable

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Device: TENS

• Registration Number: NCT02500264
• Lead Sponsor: Rabin Medical Center

Brief Summary

The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Study Start: 2015-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• at least 3 episodes of heartburn and/or regurgitation in a week for at least 3 months.
• evidence for an abnormal esophagal acid exposure on impedance-pH monitoring (tested in the last 2 years off PPI)

Exclusion Criteria

• gastric or esophagal surgery
• active peptic ulcer disease
• malignancy
• pregnancy
• uncontrolled diabetes mellitus
• severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker/defibrillator
• allergy to adhesives/patches
• severe pulmonary disease
• obesity (BMI>30)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol #2	TENS	1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium
Protocol #3	TENS	1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique
Protocol #1	TENS	interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium
Protocol #4	TENS	1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium

Primary Outcome Measures

Name	Time	Method
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment	34 days

Secondary Outcome Measures

Name	Time	Method
Esophageal acid exposure before and after treatment	34 days	Ph monitoring

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petaẖ Tiqwa, Israel