Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

NCT00387244 | Terminated Results

• 1 other identifier: SCS0506
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Intractable Pain; Chronic Pain

Keywords

Pain; Back Pain; Neurostimulation

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects With a Significant Reduction in Pain During the Temporary Trial

  Baseline and at End of trial (approximately 5 days)

Study Arms (1)

Precision for Spinal Cord Stimulation

EXPERIMENTAL

Single arm Precision for Spinal Cord Stimulation

Device: Precision for Spinal Cord Stimulation

Interventions

Precision for Spinal Cord Stimulation DEVICE

Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.

Also known as: PRECISION Spinal Cord Stimulator System (Precision System)

Precision for Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Spectrum Care

Napa, California, 94558, United States

Location

MeSH Terms

Conditions

Pain; Pain, Intractable; Chronic Pain; Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

Insufficient data collected to report results

Results Point of Contact

• Title: Director, Clinical Research Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

6619494350

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Locations

US (1)