NCT01054794

Temporary Gastric Electrical Stimulation for Gastroparesis

Temporary Gastric Neurostimulation for Gastroparesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	Gastric mucosal stimulation	The lead is a sterile, 2mm diameter insulated wire (Temporary Transvenous Pacing Lead 6416-200cm, Medtronic, Minneapolis, MN) with 2 electrodes on the distal end. The mucosal stimulation parameters(Current:10 mA; Frequency: 14Hz; Pulse width: 330 ms; Cycle ON: 0.1 s; Cycle OFF: 5 s) are within the range used for standard permanent implanted GES (Enterra therapy) within the serosa and muscle layers of the stomach, and which has been shown to be safe, without any tissue damage.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-01-22
• Last updated: 2015-06-22

Locations

1 site across 1 country: Canada