100 Participants Needed

Spinal Cord Stimulation for Pain

Recruiting at 9 trial locations
SR
CR
Overseen ByChristopher Reis, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MedtronicNeuro
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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
See 3 more

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.
See 2 more

Treatment Details

Interventions

  • Spinal Cord Stimulation
Trial OverviewThe 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
9Treatment groups
Experimental Treatment
Group I: Cohort 9: Diabetic Peripheral Neuropathy (DPN) FlowExperimental Treatment1 Intervention
Characteristics of vital signs in DPN participants
Group II: Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS)Experimental Treatment1 Intervention
Effects of integrating Neuro Sense into DTM programming
Group III: Cohort 7: Super CycleExperimental Treatment1 Intervention
Effects of longer cycle duration
Group IV: Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS)Experimental Treatment1 Intervention
Effects of decreased frequency and therapy cycling parameters
Group V: Cohort 5: Low Energy Cycling 2Experimental Treatment1 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 1Experimental Treatment1 Intervention
Effects of decreased pulse widths with increased frequency - with and without cycling parameters
Group VII: Cohort 3: Cycling EvolveExperimental Treatment1 Intervention
Subjects will be programmed to high dose (HD) stimulation with various cycling parameters
Group VIII: Cohort 2: InterleavingExperimental Treatment1 Intervention
Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
Group IX: Cohort 1: Low Energy - ContinuousExperimental Treatment1 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:

πŸ‡ΊπŸ‡Έ
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
πŸ‡ͺπŸ‡Ί
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)
πŸ‡¨πŸ‡¦
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)

Find a Clinic Near You

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