Medtronic Device Follow-Up for Spinal Conditions
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Spinal and Biologics
Disqualifiers: Concurrent trials, Inaccessible, Vulnerable, others
No Placebo Group
Approved in 4 Jurisdictions
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.12345
Is the Medtronic spinal cord stimulation device safe for humans?
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.410111213
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.
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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
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Trial 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 (Device)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Receiving eligible Medtronic device(s) from all product groupsExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tennessee Orthopaedic AllianceNashville, TN
Norton Leatherman Spine SpecialistsLouisville, KY
University of California, San Francisco (UCSF)San Francisco, CA
University of MinnesotaMinneapolis, MN
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic Spinal and BiologicsLead Sponsor
Medtronic Bakken Research CenterIndustry Sponsor
References
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]Background. Spinal cord stimulation (SCS) is effective in reducing pain from a number of differing medical conditions that are refractory to other, more conservative treatments. Much is written in the literature regarding efficacy and safety of SCS; however, no one to our knowledge has compared and reported safety and efficacy of SCS when using differing manufactured SCS devices. We undertook such a preliminary evaluation. Methods. Charts from the years 2001-2005 of our clinic's patients who had undergone trials and placement of permanent SCS systems were selected for review. All patients who had received either an Advanced Bionics SCS system (Advanced Bionics, Valencia, CA, USA), an Advanced Neuromodulation Systems (ANS) SCS system (ANS, Plano, TX, USA), or a Medtronic SCS system (Medtronic, Inc., Minneapolis, MN, USA) were given a survey to complete for data analysis. Patients were categorized into three groups: those patients having received a Medtronic (Mdt) SCS system, those patients having received an Advance Bionics (ABi) SCS system, and those patients having received an Advance Neuromodulation Systems (ANS) SCS system. Data, limited to volunteers, who gave their written consent, were analyzed for efficacy and complications. Differences in outcomes and safety were analyzed overall and according to manufacturer. Results. Eighty surveys were mailed out to 80 patients and 30 surveys were completed and returned, a return and completion rate of 37.5%. All patients showed improvement in all aspects including pain relief, sleep, functional activities, and medication use for pain control. When comparing outcomes of SCS from the three different companies, there was no significant statistical difference in average percentage pain relief, sleep improvement, and medication needed for pain control. However, there was a statistically different less change in functional improvement in the ABi group when compared to patients in the Mdt and ANS groups. Conclusions. Spinal cord stimulation improves pain, sleep, and function in patients with intractable pain. Because of the low number of patients evaluable in this study, we believe that conclusions should not be made regarding the effect of technology on outcomes or safety. We believe that an analysis of this type in larger populations is warranted to understand the role, if any, that present-day technology has on outcomes of SCS.
Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes. [2020]Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction.
Clinical evaluation of the effect of spinal cord stimulation on motor performance in patients with upper motor neuron lesions. [2019]The effect of chronic electrical stimulation of the spinal cord was evaluated in a group of 24 patients with multiple sclerosis, spinal cord injury, and degenerative disorders of the central nervous system. The systems for stimulation had been implanted from 12 to 30 months prior to completion of evaluation. At the time of completion of evaluation, 23 of the 24 patients still had implanted systems, although 6 of them had not used spinal cord stimulation because of no noticeable effect. In 3 patients stimulation had been disconnected because of technical failure of the system. In 1 patient the system had been removed 8 weeks after implantation because of inflammation in the under-skin receiver pocket. The effects on motor performance of the remaining 14 patients who had continuously active systems were improved bladder control, diminished spasticity, improved movement coordination, and increased endurance.
Electrostimulation of the nervous system for patients with demyelinating and degenerative diseases of the nervous system and vascular diseases of the extremities. [2019]The results of electrostimulation of the spinal cord for symptoms other than that of pain are recorded in this publication. 50% of patients with multiple sclerosis, primary lateral sclerosis and hereditary spino-cerebellar disorders were observed to have enduring favourable changes in neurological function during the 15 to 27 months they have been followed. The patients who were the least severely disabled had the greatest amount of increased function and were benefitted the most by the stimulation. Those who had the fewest neurological pathways affected make the most rapid progress. For example, the patient with only an ataxic or spastic gait was observed to improve faster than the patient with an ataxic and a spastic gait. The long-term effect of electrostimulation of the spinal cord on patients with these diseases is unknown at the present time. The purpose of the stimulation is to increase neurological function so that the patient can live a better life style. It is not thought that the electrical current is responsible for a 'cure' of the basic disease process. Electrostimulation of the posterior spinal roots and spinal cord, while not new, has not been used extensively for the treatment of patients with arterial disease. The patients who have responded the most dramatically to electrostimulation are those with vasospastic disorders. A larger percentage of patients showed a greater response to implanted stimulation than to transcutaneous stimulation. Electrostimulation of the nervous system is not designed to replace standard therapeutic measures of treatment of patients with vascular disease but to supplement them.
Options: A Prospective, Open-Label Study of High-Dose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain. [2020]Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome.
Magnetic resonance imaging in patients with spinal neurostimulation systems. [2007]The safety of performing magnetic resonance imaging (MRI) in patients with spinal cord stimulation (SCS) systems needs to be documented. A prospective in vivo study in patients with SCS, exploring the changes produced by MRI and the associated side effects, was performed.
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]Advances in spinal cord stimulator (SCS) technology and increasing prevalence of magnetic resonance imaging (MRI) diagnostic testing require empirical evidence describing the presence of MRI-related SCS adverse events related to off-label use of imaging. MRI safety recommendations vary based on the type of stimulator used with scant availability regarding adverse events associated with off-label MRI use. The aim of this case series is to describe the type and frequency of adverse events associated with off-label MRI use in patients with implanted SCSs.
Multiple magnetic resonance imaging in patients with implanted sacral nerve stimulator. [2021]The aim of this study was to assess possible impacts of multiple magnetic resonance imaging (MRI) scans on the function of InterStim™ sacral neurostimulator systems (SNS; Medtronic Inc.) devices and on patient's safety.
Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).
Stimulation characteristics, complications, and efficacy of spinal cord stimulation systems in patients with refractory angina: a prospective feasibility study. [2019]In a prospective study with a 1-year follow-up we evaluated: (1) the feasibility of a method for the adjustment of spinal cord stimulator (SCS) parameters, (2) complications of SCS, and (3) efficacy of SCS.
Spinal cord stimulation for the treatment of refractory unilateral limb pain syndromes. [2017]Spinal cord stimulation (SCS) is an established therapy for chronic pain. Its success depends on vigorous patient selection and good follow-up.
Pisces stimulation for motor neurone disease. [2019]Electrical stimulation of the spinal cord using the Pisces system (Medtronic Inc.) has been used for treating five patients with motor neurone disease. A short clinical description is given of each case, together with results of stimulation. In all five patients improvement was dramatic, but in two of them the progress of the disease was not halted. One, with advanced bulbar symptoms and signs, died two months after the implantation of the stimulating electrodes, although there had been initial improvement in her condition. One patient was lost to follow up. The period of stimulation in the remaining four patients ranged from eleven to six months. No medication was given other than antibiotics during the initial test phase, and all patients had physiotherapy. The results in these patients warrants continuation of this form of treatment in suitably selected patients.
Spinal cord stimulation: a quarter century of development and investigation. A review of its development and effectiveness in 1,336 cases. [2018]The past two and a half decades have seen the development of a spinal cord stimulator from the early 2-electrode fixed system to the present multielectrode computerized systems. During these 25 years, spinal cord stimulation has been studied in the treatment of motor disorders. The effectiveness was studied in 1,336 cases, including cerebral palsy (456), dystonia (173), torticollis (90), multiple sclerosis (130), spinocerebellar degeneration (71), spinal cord injury (303) and posttraumatic brain injury (113). It has become increasingly evident that the maximum therapeutic effect is achieved by virtue of the applied field variables of the spinal cord level stimulated, the field configuration, its polarity, and the frequency of the stimulation. These observations have led to investigational corollaries of the therapeutic specificity of the applied field, the neurophysiologic mechanisms of these fields and the underlying abnormal neurophysiologic substrate, which may indeed be secondary to abnormalities in the nerve impulse itself.