Medtronic Device Follow-Up for Spinal Conditions

Recruiting at 18 trial locations

Overseen By Andrew Grossbach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Spinal and Biologics

Disqualifiers: Concurrent trials, Inaccessible, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Index Surgery

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Medtronic devices treatment for spinal conditions?

Research shows that spinal cord stimulation (SCS), including Medtronic devices, can effectively reduce pain, improve sleep, and enhance daily function in patients with chronic pain conditions. Additionally, SCS has been found to improve motor performance and neurological function in patients with certain neurological disorders. ^{1 2 3 4 5}

Is the Medtronic spinal cord stimulation device safe for humans?

Research shows that Medtronic spinal cord stimulation devices are generally safe for humans, with a low rate of serious adverse events like implant site infections occurring in less than 1% of cases. ^{1 6 7 8 9}

How is the Medtronic device treatment for spinal conditions different from other treatments?

The Medtronic device treatment, which involves spinal cord stimulation, is unique because it uses electrical impulses to improve neurological function and manage pain, unlike traditional treatments that may rely on medication or surgery. This method has shown promise in various conditions, including chronic pain and motor disorders, by targeting specific areas of the spinal cord to achieve therapeutic effects. ^{4 10 11 12 13}

Eligibility Criteria

This trial is for adults who need a Medtronic Cranial and Spinal Technology device for conditions like spinal tumors, scoliosis, or spinal trauma. Participants must give written consent, agree to follow-up assessments up to 24 months post-surgery, and not be in other trials that could affect results.

Inclusion Criteria

Subject provides written informed consent per institution and/or geographical requirements

Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s)

I am at least 18 years old or meet the legal age requirement.

Exclusion Criteria

Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance)

Subject who is, or is expected to be, inaccessible for all required follow-up visits

Subject with exclusion criteria required by local law

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Medtronic devices for cranial and/or spinal indications and undergo surgery

Index Surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of surgical success, fusion success, and device performance

24 months

Long-term Follow-up

Continued monitoring of device performance and adverse events

Up to 24 months

Treatment Details

Interventions

• Medtronic devices

Trial Overview The study is tracking the performance and safety of Medtronic devices used in surgeries for various cranial and spinal issues. Patients will have routine clinical care data collected from before surgery until up to two years after the procedure.

Participant Groups

Group I: Receiving eligible Medtronic device(s) from all product groups Experimental Treatment 1 Intervention

Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Medtronic devices is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Medtronic Neurostimulation Systems for:

• Chronic, intractable pain of the trunk and/or limbs
• Cranial procedures including tumor resections, cranial biopsies, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead, and probe placement

Approved in European Union as Medtronic Neurostimulation Systems for:

• Chronic, intractable pain of the trunk and/or limbs
• Cranial procedures including tumor resections, cranial biopsies, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead, and probe placement

Approved in Canada as Medtronic Spinal Cord Stimulation Devices for:

• Chronic, intractable pain of the trunk and/or limbs

Approved in Japan as Medtronic Cranial Devices for:

• Cranial procedures including tumor resections, cranial biopsies, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead, and probe placement

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Recruited

10,600+

Medtronic Bakken Research Center

Industry Sponsor

Trials

98

Recruited

78,500+

Denise L. Blomquist

Medtronic Bakken Research Center

Chief Executive Officer

Bachelor's degree in Accounting from the University of Wisconsin - Madison

Dr. Kim Chaffin

Medtronic Bakken Research Center

Chief Medical Officer

MD

Findings from Research

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

In a study of 420 patients with chronic back and/or leg pain, spinal cord stimulation (SCS) significantly reduced pain scores from an average of 7.2 to 2.4 after a mean follow-up of about 208 days, indicating strong efficacy in pain management.

The customizable nature of the SCS systems, which allowed for tailored neurostimulation programs based on patient feedback, suggests that personalized treatment approaches can enhance pain relief in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes. Metzger, CS., Hammond, MB., Pyles, ST., et al.[2020]

In a study of 24 patients with conditions like multiple sclerosis and spinal cord injury, chronic electrical stimulation of the spinal cord showed positive effects on motor performance in 14 patients who actively used the system, including improved bladder control and reduced spasticity.

Despite some technical issues and lack of noticeable effects in a few patients, the majority experienced benefits such as better movement coordination and increased endurance, suggesting that spinal cord stimulation can be an effective intervention for certain neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the effect of spinal cord stimulation on motor performance in patients with upper motor neuron lesions. Campos, RJ., Dimitrijevic, MM., Faganel, J., et al.[2019]

In a study of patients with multiple sclerosis, primary lateral sclerosis, and hereditary spino-cerebellar disorders, 50% experienced lasting improvements in neurological function after spinal cord electrostimulation over a follow-up period of 15 to 27 months, particularly benefiting those with less severe disabilities.

Electrostimulation appears to enhance neurological function rather than cure the underlying disease, and it has shown more dramatic responses in patients with vasospastic disorders, suggesting it may serve as a supplementary treatment alongside standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrostimulation of the nervous system for patients with demyelinating and degenerative diseases of the nervous system and vascular diseases of the extremities. Dooley, DM., Sharkey, J.[2019]

In a study of 44 patients with failed back surgery syndrome, spinal cord stimulation (SCS) using high-frequency programming (1,000 Hz) resulted in significant pain relief, with overall pain scores improving from 7.5 to 3.8 after 3 months (P < 0.01).

The majority of patients reported high satisfaction with the treatment, with 84% satisfied and 78.1% willing to recommend SCS, while adverse events were common but resolved without reoperation, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options: A Prospective, Open-Label Study of High-Dose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain. Benyamin, R., Galan, V., Hatheway, J., et al.[2020]

A study involving 31 patients with spinal cord stimulation (SCS) systems showed that undergoing MRI scans is generally safe, with no serious complications or harm reported during the procedure.

While some minor issues like increased temperature at the generator site and telemetry difficulties were noted, these did not affect patient safety or lead to reprogramming of the SCS systems, indicating that MRI can be performed safely in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in patients with spinal neurostimulation systems. De Andres, J., Valía, JC., Cerda-Olmedo, G., et al.[2007]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

In a study involving 16 patients who underwent a total of 72 MRI scans over 17 years, no negative effects on the function of InterStim™ sacral neurostimulator systems were observed, indicating that these devices can safely coexist with multiple MRI examinations.

Patients reported no pain or discomfort during or after the MRI scans, and assessments of the device's function showed no significant changes, confirming the safety and efficacy of the SNS even after repeated imaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple magnetic resonance imaging in patients with implanted sacral nerve stimulator. Heidler, S., Ostermann, S., Kuglitsch, M., et al.[2021]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

In a study of 22 patients with severe angina, spinal cord stimulation (SCS) significantly reduced the frequency of anginal attacks and the need for glyceryl trinitrate (GTN) over a 1-year follow-up, demonstrating its efficacy as an adjuvant therapy.

The method for adjusting SCS parameters was found to be feasible, with no significant changes in stimulation settings over the year for patients without lead dislocations, although 6 patients did experience lead dislocation requiring surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation characteristics, complications, and efficacy of spinal cord stimulation systems in patients with refractory angina: a prospective feasibility study. de Jongste, MJ., Nagelkerke, D., Hooyschuur, CM., et al.[2019]

Spinal cord stimulation (SCS) is an effective treatment for chronic pain, particularly in patients with refractory unilateral limb pain syndrome (RULPS), with an initial response rate of 87% that stabilizes at 84% after two years.

A significant portion of patients experienced benefits, including a reduction in pain medication (56%) and a return to work (46.8%), highlighting the importance of careful patient selection and follow-up for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for the treatment of refractory unilateral limb pain syndromes. Kumar, A., Felderhof, C., Eljamel, MS.[2017]

Electrical stimulation of the spinal cord using the Pisces system showed dramatic improvements in motor function for five patients with motor neurone disease, although the disease progression was not halted in all cases.

Despite one patient experiencing initial improvement, two patients faced severe disease progression, highlighting the need for careful patient selection and further research into the long-term efficacy and safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pisces stimulation for motor neurone disease. Plotkin, R.[2019]

Spinal cord stimulation has evolved significantly over 25 years, with studies involving 1,336 cases across various motor disorders, demonstrating its effectiveness in conditions like cerebral palsy and spinal cord injury.

The therapeutic effects of spinal cord stimulation are influenced by specific parameters such as the spinal cord level targeted, field configuration, polarity, and stimulation frequency, highlighting the importance of tailored approaches for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a quarter century of development and investigation. A review of its development and effectiveness in 1,336 cases. Waltz, JM.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the effect of spinal cord stimulation on motor performance in patients with upper motor neuron lesions. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Electrostimulation of the nervous system for patients with demyelinating and degenerative diseases of the nervous system and vascular diseases of the extremities. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Options: A Prospective, Open-Label Study of High-Dose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in patients with spinal neurostimulation systems. [2007]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Multiple magnetic resonance imaging in patients with implanted sacral nerve stimulator. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Stimulation characteristics, complications, and efficacy of spinal cord stimulation systems in patients with refractory angina: a prospective feasibility study. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for the treatment of refractory unilateral limb pain syndromes. [2017]

12. Austria pubmed.ncbi.nlm.nih.gov

Pisces stimulation for motor neurone disease. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a quarter century of development and investigation. A review of its development and effectiveness in 1,336 cases. [2018]