Spinal Cord Stimulation for Pain

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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