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

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06229470
• Lead Sponsor: Saluda Medical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-03-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

Lakeside Spine and Pain; 🇺🇸 Lake Havasu City, Arizona, United States

Spanish Hills Interventional Pain Specialists; 🇺🇸 Camarillo, California, United States

Pain Consultants of San Diego; 🇺🇸 La Mesa, California, United States

Pacific Research Institute; 🇺🇸 Santa Rosa, California, United States

Boomerang Healthcare; 🇺🇸 Walnut Creek, California, United States

DBPS Research; 🇺🇸 Greenwood Village, Colorado, United States

Pohlman Pain Associates; 🇺🇸 Delray Beach, Florida, United States

Horizon Clinical Research; 🇺🇸 Jasper, Georgia, United States

Rockford Pain Center; 🇺🇸 Rockford, Illinois, United States

Goodman Campbell Brain and Spine; 🇺🇸 Carmel, Indiana, United States

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