Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

Stopped early · Not applicable

Conditions studied: Pain, Intractable Pain, Chronic Pain

In brief

The primary objective of this study is to evaluate the efficacy of spinal cord stimulation using the Precision implantable neurostimulation device for chronic and intractable pain of the trunk and or limbs in patients who have failed treatment with an intraspinal infusion pump or other SCS system.

Key facts

Study ID

NCT00387244

Run by

Boston Scientific Corporation

People needed

7

Starts

2006-08-01

Expected to finish

2008-04-01

Last updated by the study team

2020-12-17

Who can join

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

You may qualify if…

• Have chronic and intractable neuropathic pain of the trunk and/or limbs of moderate to severe intensity and have failed treatment with an intraspinal infusion pump or other SCS device. Determination of failure of treatment will be based on subject feedback. Subjects with an active intraspinal infusion pump but with inadequate pain control will be allowed to participate;
• Be 18 years of age or older;
• Be an appropriate candidate for the surgical procedures required for this study;
• Be willing and able to comply with all study related procedures and visits;
• Be capable of reading and understanding patient information materials and giving written informed consent.

You may not qualify if…

• Have failed immediate past treatment with an intraspinal infusion pump or other SCS device because of technical reasons associated with the device such as unresolved lead migration, battery depletion, etc.;
• Have any evidence of neurologic instability requiring surgery;
• Have any significant medical condition that in the opinion of the investigator may interfere with the conduct of the study or may adversely affect the subject's safety during the study;
• Have any other active implantable device with the exception of a intraspinal infusion pump for pain medications;
• Are pregnant or lactating or planning to become pregnant in the next year;
• Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other investigational drug or device trial while on this study.

Where it is running

• Spectrum Care — Napa, California, United States

Full record on ClinicalTrials.gov

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