Chronic Pain
Conditions
Brief summary
The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
Interventions
A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Sponsors
Saluda Medical Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain. * Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]). * Back pain score ≥ 6 cm (VAS). * Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits. * Subject is not pregnant and not \<18 years of age.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System | through 6-months post-implant | physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) Pain | through 6-months post-implant | Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\]) |
| Change in PROMIS-29+2 | through 6-months post-implant | PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. |
| Change in PROMIS-10 Global Health | through 6-months post-implant | 10-item instrument that assesses Physical Health and Mental Health |
Countries
United States
Outcome results
None listed