Neuropathic Pain, Pain
Conditions
Keywords
Spinal Cord Stimulation
Brief summary
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.
Detailed description
The clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by SCS and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.
Interventions
DEVICEPrecision Spinal Cord Stimulation (SCS)
Various SCS device programming parameters
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10. * Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs * Be 18 years of age or older * Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition * Be able to use pen tablet to document regions of paresthesia and pain * Be able to lie in the supine position for 45 minutes at a minimum * Be able to verbally report qualitative and quantitative aspects of paresthesia sensations. * Have a paresthesia threshold on a standard program below 4mA while in the supine position * Have at minimum the upper contact of one lead below T8 and the lower contact above T11 vertebral levels * Be willing and able to comply with study-related procedure * Agree to study requirements and provides written Informed Consent
Exclusion criteria
* Unable to read, write, speak, and understand English * Currently pregnant or planning to become pregnant during the course of the study * Have negative finding in any of the pre-screening and screening requirements * Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels * Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities * Have a drug pump and/or a non-Precision neurostimulation device (regardless of whether active or inactive) * Have had any interventional pain procedure or surgeries (including Interlaminar epidural steroid injection, Transforaminal epidural steroid injection, Caudal epidural steroid injection, Selective nerve root block, Intraarticular lumbar facet injection, Sacroiliac joint injection, Piriformis muscle injection, Trochanteric bursa injection, Hip/knee joint injections, Medial branch block (innervates facet joint), Pulsed radiofrequency neurotomy medial branches, Pulsed radiofrequency dorsal root ganglion, Thermal (high temperature) radiofrequency neurotomy medial branches, Trigger point injections, and Botulinum toxin injections) involving the spine within the past 30 days * Have any condition that is likely to confound evaluation of study endpoints. Conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm) | Immediately post-procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Group Spinal Cord Stimulation (SCS) Treatment Group | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)
Time frame: Immediately post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm) | 0.6202 Correlation coefficient |