Clinical trial NCT05177354: Medtronic Closed-Loop Spinal Cord Stimulation System
Official title: Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Leg Pain
Upper Limb Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Overstimulation Sensation
timeFrame: 30 days from device activation
Secondary outcomes:
measure: Responder Rate for Treatment of Overall Pain
timeFrame: 3 months from device activation
measure: Responder Rate for Treatment of Low-back Pain
timeFrame: 3 months from device activation
measure: Responder Rate for Treatment of Leg Pain
timeFrame: 3 months from device activation
Other outcomes:
Locations:
city: Bella Vista
country: Australia
facility: Sydney Pain Specialists
state: New South Wales
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Hurstville
country: Australia
facility: Australian Medical Research
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Pain Research Centre
state: New South Wales
city: Noosa Heads
country: Australia
facility: Sunshine Coast Clinical Research
state: Queensland
city: Kew
country: Australia
facility: Precision Brain Spine and Pain Center
state: Victoria
Study officials:
affiliation: Genesis Research Services
name: Marc Russo, MD
role: PRINCIPAL_INVESTIGATOR
References: