Medtronic Closed-Loop Spinal Cord Stimulation System

Medtronic

Status: Active, not recruiting

Conditions: Leg Pain; Upper Limb Pain; Low Back Pain

Treatments: Device: Inceptiv

Study type: Interventional

Funder types: Industry

Identifiers

NCT05177354

MDT21017

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: Inceptiv