Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

Chronic Pain Clinical Trial

— Neural Panel  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229470
• Other study ID #: D103977
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: May 2024
• Source: Saluda Medical Pty Ltd
• Contact: Angela Leitner, MS
• Phone: 651-208-4223
• Email: angela.leitner[@]saludamedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Evoke Spinal Cord Stimulation (SCS) System
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.

Locations

Country	Name	City	State
United States	Spanish Hills Interventional Pain Specialists	Camarillo	California
United States	Goodman Campbell Brain and Spine	Carmel	Indiana
United States	Garden State Pain and Orthopedics	Clifton	New Jersey
United States	Pohlman Pain Associates	Delray Beach	Florida
United States	Metro Anesthesia & Pain Management	Des Moines	Iowa
United States	Spine and Joint Institute	Glen Burnie	Maryland
United States	Tricity Research Center, LLC	Grand Island	Nebraska
United States	Carolinas Center for Advanced Management of Pain	Greenville	South Carolina
United States	Advanced Pain Institute	Hammond	Louisiana
United States	Horizon Clinical Research	Jasper	Georgia
United States	Pain Consultants of San Diego	La Mesa	California
United States	Lakeside Spine and Pain	Lake Havasu City	Arizona
United States	Restorative Pain Institute	Louisville	Kentucky
United States	Premier Pain Treatment Institute	Loveland	Ohio
United States	Reno Tahoe Pain Associates	Reno	Nevada
United States	Pain Clinic of Michigan	Rochester Hills	Michigan
United States	Rockford Pain Center	Rockford	Illinois
United States	Pacific Research Institute	Santa Rosa	California
United States	Precision Spine Care	Tyler	Texas
United States	Victoria Pain and Rehabilitation Center	Victoria	Texas
United States	Boomerang Healthcare	Walnut Creek	California
United States	Seaside Clinical Research Institute	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Saluda Medical Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System	physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System	through 6-months post-implant
Secondary	Change in Visual Analogue Scale (VAS) Pain	Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])	through 6-months post-implant
Secondary	Change in PROMIS-29+2	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.	through 6-months post-implant
Secondary	Change in PROMIS-10 Global Health	10-item instrument that assesses Physical Health and Mental Health	through 6-months post-implant