Medtronic Closed-Loop Spinal Cord Stimulation System

Low Back Pain Clinical Trial

Official title:

Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05177354
• Other study ID #: MDT21017
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: August 31, 2025
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Leg Pain
• Low Back Pain
• Upper Limb Pain

Intervention

Device:
• Inceptiv
Implantable Neurostimulator with Neuro Sense

Locations

Country	Name	City	State
Australia	Sydney Pain Specialists	Bella Vista	New South Wales
Australia	Genesis Research Services	Broadmeadow	New South Wales
Australia	Australian Medical Research	Hurstville	New South Wales
Australia	Precision Brain Spine and Pain Center	Kew	Victoria
Australia	Sunshine Coast Clinical Research	Noosa Heads	Queensland
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Sydney Pain Research Centre	Wahroonga	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in overstimulation sensation	Comparison of Neuro Sense On vs Off at in-clinic testing for low-back and/or leg pain subjects. Subjects will perform protocol prescribed activities and rate the intensity of the sensation on a 5-point Likert scale. The average intensity scores during each period will be calculated for each subject. The proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Neuro Sense On compared to Neuro Sense Off will be calculated, with a one-sided 97.5% lower bound.	30 days from device activation
Secondary	Responder rate for treatment of overall pain	Low-back and/or leg pain subjects	3 months from device activation
Secondary	Responder rate for treatment of low-back pain	Low-back pain subjects (baseline back VAS =60mm)	3 months from device activation
Secondary	Responder rate for treatment of leg pain	Leg pain subjects (baseline leg VAS =60mm)	3 months from device activation