Clinical trial NCT06229470: Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain
Official title: A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
timeFrame: through 6-months post-implant
Secondary outcomes:
measure: Change in Visual Analogue Scale (VAS) Pain
timeFrame: through 6-months post-implant
measure: Change in PROMIS-29+2
timeFrame: through 6-months post-implant
measure: Change in PROMIS-10 Global Health
timeFrame: through 6-months post-implant
Other outcomes:
Locations:
city: Lake Havasu City
country: United States
facility: Lakeside Spine and Pain
state: Arizona
city: Camarillo
country: United States
facility: Spanish Hills Interventional Pain Specialists
state: California
city: La Mesa
country: United States
facility: Pain Consultants of San Diego
state: California
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Walnut Creek
country: United States
facility: Boomerang Healthcare
state: California
city: Greenwood Village
country: United States
facility: DBPS Research
state: Colorado
city: Delray Beach
country: United States
facility: Pohlman Pain Associates
state: Florida
city: Jasper
country: United States
facility: Horizon Clinical Research
state: Georgia
city: Rockford
country: United States
facility: Rockford Pain Center
state: Illinois
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Des Moines
country: United States
facility: Metro Anesthesia & Pain Management
state: Iowa
city: Louisville
country: United States
facility: Restorative Pain Institute
state: Kentucky
city: Hammond
country: United States
facility: Advanced Pain Institute
state: Louisiana
city: Glen Burnie
country: United States
facility: Spine and Joint Institute
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: Rochester Hills
country: United States
facility: Pain Clinic of Michigan
state: Michigan
city: Grand Island
country: United States
facility: Tricity Research Center, LLC
state: Nebraska
city: Reno
country: United States
facility: Reno Tahoe Pain Associates
state: Nevada
city: Clifton
country: United States
facility: Garden State Pain and Orthopedics
state: New Jersey
city: Wilmington
country: United States
facility: Seaside Clinical Research Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Loveland
country: United States
facility: Premier Pain Treatment Institute
state: Ohio
city: Greenville
country: United States
facility: Carolinas Center for Advanced Management of Pain
state: South Carolina
city: Corpus Christi
country: United States
facility: Institute of Precision Pain Medicine
state: Texas
city: Victoria
country: United States
facility: Victoria Pain and Rehabilitation Center
state: Texas
Study officials:
References: