NCT01106404

RestoreSensor Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to gather clinical information on subjects' experiences with and without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).

Detailed description

This study is a multi-center, prospective, open-label, randomized, crossover study that is designed to gather clinical information on subjects' experiences with the use of the new feature of the RestoreSensor implantable neurostimulator. Current spinal cord stimulators for chronic intractable pain stimulate targeted nerves along the spine using electrical impulses. The stimulation interferes with the transmission of pain signals to the brain replacing painful sensations with a tingling sensation called paresthesia. Variation in the intensity of neurostimulation with body position is a challenge for some patients implanted with conventional spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. Patients need to manually adjust their stimulation using the patient programmer to maintain their comfort level during position changes. The AdaptiveStim feature of the RestoreSensor neurostimulator was developed to address this challenge by improving pain relief and/or convenience relative to manual programming adjustments.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	RestoreSensor Neurostimulation System	Adjustments to stimulation settings are automatic when the AdaptiveStim feature of the device is turned "ON" and manual when the AdaptiveStim feature of the device is turned "OFF".

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-04-19
• Last updated: 2012-08-30
• Results posted: 2012-08-01

Locations

10 sites across 1 country: United States