SCS Research Study

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)

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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