Chronic Pain, Pain, Chronic
Conditions
Brief summary
Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.
Interventions
DEVICEAPM
Investigational programming software module, the Assisted Programming Module (APM)
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 has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication. * Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System | end of trial period; 1 month and 3 months post-implant | Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System |
| Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System | end of trial period; 1 month and 3 months post-implant | Change in programming parameters (e.g., stimulation frequency \[Hz\], pulse width \[µs\], amplitude \[mA\]) measured by the Evoke SCS System |
Countries
United States
Outcome results
None listed