Clinical Trial: Temporary Gastric Electrical Stimulation for Gastroparesis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Temporary Gastric Neurostimulation for Gastroparesis

Brief Summary:

This is a prospective study of temporary gastric mucosal electrical stimulation (tGES) in 30 patients with gastroparesis (GP). After a 7 day baseline assessment of symptoms, subjects will have an endoscopically-placed tGES lead implanted into the mucosa of the antrum. This lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a nasojejunal feeding tube, although much thinner. It is then attached to a programmable battery pack which provides the desired level of stimulation.

Patients will then be randomized to 7 days OFF or 7 days ON stimulation in a double-blind fashion. After 7 days, subjects will crossover to the other study arm (ie ON patients will be switched off; OFF patients will be switched on). Symptoms and QoL measures will be assessed at baseline, ON, and OFF periods. Serum ghrelin and other hormones, as well as EGG will be assayed after 6 days in each arm.

Detailed Summary:
Sponsor: University of Calgary

Current Primary Outcome: Changes in patient symptoms during the ON and OFF periods of tGES stimulation. [ Time Frame: daily x 6 days in each phase of study (ON and OFF) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 1. Changes in serum ghrelin and leptin between ON and OFF periods of tGES stimulation in GP patients. 2. Changes in gastric electrical activity between ON and OFF periods of tGES stimulation in GP patients [ Time Frame: Once during each study phase (ON and OFF) ]

Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: January 19, 2010
Date Started: December 2009
Date Completion:
Last Updated: June 19, 2015
Last Verified: June 2015