Spinal Cord Stimulation for Pain

No longer recruiting at 9 trial locations

Overseen By Christopher Reis, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Disqualifiers: Pregnancy, Untreated psychiatric, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 8 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different settings of spinal cord stimulation, a therapy using electrical impulses, can relieve pain. Several groups test various stimulation techniques to determine which provides the best pain relief. Individuals who have used a Medtronic neurostimulation device for at least a month and can distinguish between their usual pain and other types are suitable candidates. The goal is to find the most effective way to use these devices to improve daily life for those with chronic pain. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management solutions.

Do I need to stop my current medications for the trial?

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

What prior data suggests that Spinal Cord Stimulation is safe for pain relief?

Research has shown that spinal cord stimulation (SCS) is generally well-tolerated. Studies have found that SCS can safely manage chronic pain. In one study, SCS was monitored for over two years and showed positive results. Some participants had their devices removed, usually due to insufficient pain relief rather than safety concerns.

Another report found that serious side effects were rare, though minor issues like discomfort or infections at the implant site can occur. These risks are usually manageable. Additionally, the FDA has approved SCS for certain types of pain, recognizing it as safe for those conditions.

Overall, SCS is considered safe for most people, but like any medical treatment, it may involve risks. It is important to consult healthcare providers to determine if SCS is a suitable option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation for pain management because it offers innovative approaches that differ from traditional methods like medications or surgeries. This trial explores various stimulation techniques, such as low energy, interleaving pulses, and high-dose cycling, which may offer more personalized pain relief. Unique methods like Differential Targeted Multiplexed (DTM) programming integrate advanced technology, potentially enhancing effectiveness for conditions like diabetic peripheral neuropathy. By tailoring stimulation parameters to individual needs, these treatments aim to provide more effective and targeted pain management options.

What evidence suggests that this trial's treatments could be effective for pain relief?

Research has shown that spinal cord stimulation (SCS) effectively reduces chronic pain. This trial will assign participants to different cohorts to evaluate various SCS approaches. Studies comparing SCS to regular medical care have demonstrated significant pain relief and improved quality of life for patients with SCS over 6, 12, and 24 months. Another review found SCS particularly beneficial for individuals with long-term back and leg pain, highlighting its advantages after years of use. Overall, SCS ranks among the most effective treatments for managing ongoing pain. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 22 with limb or back pain, who have had a Medtronic rechargeable neurostimulation system implanted for at least one month. Participants must understand English, be able to follow the study's procedures and document their experience. Pregnant women or those not using birth control are excluded.

Inclusion Criteria

You are willing and able to comply with all study procedures, including diary completion, and visits.

Willing and able to provide signed and dated informed consent

Capable of comprehending and consenting in English

Exclusion Criteria

You have a non-rechargeable neurostimulator, and it's impossible to predict how long the battery will last.

You have a device implanted in your body that is being used for a purpose that hasn't been approved by the authorities.

You are already participating or planning to participate in another study that could affect the results of this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal cord stimulation with various programming settings to assess pain relief

Up to 8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulation

Trial Overview

The SCS Research Study is examining how different spinal cord stimulation settings affect pain relief in patients with chronic limb and back pain. It focuses on personalizing treatment by assessing outcomes specific to each participant.

How Is the Trial Designed?

Group I: Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Experimental Treatment 1 Intervention

Characteristics of vital signs in DPN participants

Group II: Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Experimental Treatment 1 Intervention

Effects of integrating Neuro Sense into DTM programming

Group III: Cohort 7: Super Cycle Experimental Treatment 1 Intervention

Effects of longer cycle duration

Group IV: Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Experimental Treatment 1 Intervention

Effects of decreased frequency and therapy cycling parameters

Group V: Cohort 5: Low Energy Cycling 2 Experimental Treatment 1 Intervention

Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4)

Group VI: Cohort 4: Low Energy Cycling 1 Experimental Treatment 1 Intervention

Effects of decreased pulse widths with increased frequency - with and without cycling parameters

Group VII: Cohort 3: Cycling Evolve Experimental Treatment 1 Intervention

Subjects will be programmed to high dose (HD) stimulation with various cycling parameters

Group VIII: Cohort 2: Interleaving Experimental Treatment 1 Intervention

Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes

Group IX: Cohort 1: Low Energy - Continuous Experimental Treatment 1 Intervention

Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes

Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)
• Phantom limb/stump pain
• Ischemic pain of vascular origin
• Complex regional pain syndrome
• Pain after an amputation
• Visceral abdominal pain and perineal pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12321793/

The effectiveness of spinal cord stimulation combined with ...

This review aims to synthesize current evidence regarding pain relief, functional improvement, and quality of life outcomes associated with this ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ...

This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ...

compared conservative medical management (CMM) to SCS in this patient population (48 CMM, 52 SCS patients) and measured outcomes at 6, 12, and 24 months. SCS ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1526590023004704

Real World Characterization of Chronic Pain, Success ...

Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation ...

5.

janesthanalgcritcare.biomedcentral.com

janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-024-00219-6

addressing persistent doubts in spinal cord stimulation

Over the past 50 years, spinal cord stimulation (SCS) has emerged as one of the most effective treatments for chronic pain.

6.

tandfonline.com

tandfonline.com/doi/full/10.2217/pmt-2022-0091

Long-term Safety of Spinal Cord Stimulation Systems in A ...

Abstract. Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11929510/

Spinal Cord Stimulation Explantation and Chronic Pain

SCS efficacy varies, with explantation rates reaching up to 38%, often due to inadequate pain relief. Most explantations occur within the first ...

8.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P010032S189B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Effect and safety of spinal cord stimulation for treatment of chronic pain ... pain management: outcomes and predictors of revisions of spinal cord stimulators.