SCS Research Study

Medtronic

Status: Active, not recruiting

Conditions: Trunk Pain; Limb Pain

Treatments: Device: Spinal Cord Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03763708

MDT18036

Details and patient eligibility

About

To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Full description

This post market study will measure the following:

• Numeric Pain Rating Scale
• Satisfaction and Stimulation Assessment
• Stimulation feedback
• Stimulation parameters
• Anatomical locations of active contacts
• Stimulation thresholds
• Location of paresthesia
• Oswestry Disability Index
• European Quality of Life 5-Dimensions
• To characterize non-invasive health monitoring data

Enrollment: 360 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 22 years of age or older
2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. Willing and able to comply with all study procedures, including diary completion, and visits
6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion criteria

1. Implanted with neurostimulation system for an off-label indication
2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
4. Has untreated major psychiatric comorbidity
5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 1 patient group

Spinal Cord Stimulation

Experimental group

Description:

Each subject will be programmed to different settings.

Treatment:

Device: Spinal Cord Stimulation