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

Clalit Health Services

Status: Unknown

Conditions: Gastroesophageal Reflux Disease

Treatments: Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT02500264

0293-15-RMC

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Protocol #1

Active Comparator group

Description:

interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium

Treatment:

Device: TENS

Protocol #2

Active Comparator group

Description:

1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium

Treatment:

Device: TENS

Protocol #3

Active Comparator group

Description:

1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique

Treatment:

Device: TENS

Protocol #4

Active Comparator group

Description:

1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium

Treatment:

Device: TENS