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

September 19, 2017 updated by: Ram Dickman, Rabin Medical Center
The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petaẖ Tiqwa, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • ram dickman, professor
        • Sub-Investigator:
          • amani bashara, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
Time Frame: 34 days
34 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal acid exposure before and after treatment
Time Frame: 34 days
Ph monitoring
34 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: ram dickman, professor, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0293-15-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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