RestoreSensor Study

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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).

Key facts

Study ID

NCT01106404

Run by

MedtronicNeuro

People needed

79

Starts

2010-04-01

Expected to finish

2011-01-01

Last updated by the study team

2012-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the indications as an appropriate surgical candidate (after successful SCS screening trial) for implant of a neurostimulation system for spinal cord stimulation (SCS) treatment of trunk and/or limb pain, per labeled indications
• 18 years of age or older
• Willing and able to attend visits and comply with the study protocol
• Capable of using the patient programmer and recharging the neurostimulator (INS), able to read and answer questionnaires in English, without assistance of a caregiver
• Males and non-pregnant females

You may not qualify if…

• Has had a prior implantable SCS neurostimulation system
• Currently enrolled, or plans to enroll in another investigational device or drug trial during the study
• Has unresolved legal issues related to their pain condition for which they would be receiving neurostimulation
• Requires cervical placement of leads.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Oceanside, California, United States
• Study site — Edina, Minnesota, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Eugene, Oregon, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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