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SCS Research Study

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Medtronic

Status

Terminated

Conditions

Trunk Pain
Limb Pain

Treatments

Device: Spinal Cord Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03763708
MDT18036

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 22 years of age or older
  2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
  3. Willing and able to provide signed and dated informed consent
  4. Capable of comprehending and consenting in English
  5. Willing and able to comply with all study procedures, including diary completion, and visits
  6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion criteria

  1. Implanted with neurostimulation system for an off-label indication
  2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
  3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
  4. Has untreated major psychiatric comorbidity
  5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 9 patient groups

Cohort 1: Low Energy - Continuous
Experimental group
Description:
Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes
Treatment:
Device: Spinal Cord Stimulation
Cohort 2: Interleaving
Experimental group
Description:
Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
Treatment:
Device: Spinal Cord Stimulation
Cohort 3: Cycling Evolve
Experimental group
Description:
Subjects will be programmed to high dose (HD) stimulation with various cycling parameters
Treatment:
Device: Spinal Cord Stimulation
Cohort 4: Low Energy Cycling 1
Experimental group
Description:
Effects of decreased pulse widths with increased frequency - with and without cycling parameters
Treatment:
Device: Spinal Cord Stimulation
Cohort 5: Low Energy Cycling 2
Experimental group
Description:
Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4)
Treatment:
Device: Spinal Cord Stimulation
Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS)
Experimental group
Description:
Effects of decreased frequency and therapy cycling parameters
Treatment:
Device: Spinal Cord Stimulation
Cohort 7: Super Cycle
Experimental group
Description:
Effects of longer cycle duration
Treatment:
Device: Spinal Cord Stimulation
Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS)
Experimental group
Description:
Effects of integrating Neuro Sense into DTM programming
Treatment:
Device: Spinal Cord Stimulation
Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow
Experimental group
Description:
Characteristics of vital signs in DPN participants
Treatment:
Device: Spinal Cord Stimulation

Trial documents
2

Trial contacts and locations

9

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Central trial contact

SCS Research Clinical Research Study Team

Data sourced from clinicaltrials.gov

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