OPTIONS Spinal Cord Stimulation Programming Parameters

Medtronic

Status: Completed

Conditions: Pain, Intractable

Treatments: Device: Spinal Cord Stimulation (SCS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02503787

1675

Details and patient eligibility

About

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Full description

Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.

The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
• Willing and able to provide a signed and dated informed consent
• At least 18 years old at the time of informed consent
• Willing and able to attend visits and comply with the study protocol
• Capable of using the patient programmer and recharging the neurostimulator
• Willing to not increase pain medications from baseline through the 3-Month Visit

Exclusion criteria

• Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
• Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
• Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
• Implanted with a cardiac device (e.g., pacemaker, defibrillator)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Open label treatment

Other group

Description:

Spinal Cord Stimulation (SCS)

Treatment:

Device: Spinal Cord Stimulation (SCS)