Medtronic Closed-Loop Spinal Cord Stimulation System

Not Applicable

Active, not recruiting

Brief Summary: The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.

Recruitment & Eligibility

Inclusion Criteria

18 years of age or older
Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
If being treated for low-back and/or leg pain,
- the baseline overall^ Visual Analog Scale is ≥ 60 mm and
- baseline back and/or leg pain Visual Analog Scale is ≥60 mm. ^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale.
If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain
On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial
Willing and able to provide signed and dated informed consent
Willing and able to comply with all study procedures and visits

Exclusion Criteria

Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator
Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
Be involved in an injury claim or under current litigation

Arm && Interventions

Group	Intervention	Description
Treatment	Inceptiv	-

Primary Outcome Measures

Name	Time	Method
Reduction in Overstimulation Sensation	30 days from device activation	The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.

Secondary Outcome Measures

Name	Time	Method
Responder Rate for Treatment of Overall Pain	3 months from device activation	Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%.
Responder Rate for Treatment of Low-back Pain	3 months from device activation	Responder rate defined as a reduction in back pain VAS of at least 50%.
Responder Rate for Treatment of Leg Pain	3 months from device activation	Responder rate defined as a reduction in leg pain VAS of at least 50%.

Locations (7): Royal North Shore Hospital
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Saint Leonards, New South Wales, Australia
Sydney Pain Specialists
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Bella Vista, New South Wales, Australia
Sydney Pain Research Centre
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Wahroonga, New South Wales, Australia
Genesis Research Services
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Broadmeadow, New South Wales, Australia
Australian Medical Research
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Hurstville, New South Wales, Australia
Precision Brain Spine and Pain Center
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Kew, Victoria, Australia
Sunshine Coast Clinical Research
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Noosa Heads, Queensland, Australia