Chronic Pain, Neuropathic Pain, Pain
Conditions
Keywords
Saluda, Spinal Cord Stimulation
Brief summary
This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.
Interventions
DEVICEEvoke
The Saluda Medical Evoke® CL-SCS System (Evoke System). The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode.
Sponsors
Saint Francis Hospital
Saluda Medical Americas, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be 18 years of age or older at the time of enrollment. Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician. Be willing and capable of giving informed consent. Be willing and able to comply with study-related requirements, procedures, and visits.
Exclusion criteria
Subject is pregnant or nursing. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS). Have prior experience with SCS. Be concomitantly participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS - Visual Analog Scale | Baseline to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| PROMIS-29 | Baseline to 12 months |
Countries
United States
Contacts
CONTACTAmy Young, RN BSN DMPNA
PRINCIPAL_INVESTIGATORTimothy Deer, MD
Spine and Nerve Center of Saint Francis Hospital
Outcome results
None listed