Active — Not RecruitingNot Applicable

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

United States250 participantsStarted 2024-03-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System

Timeframe: through 6-months post-implant

Trial details

NCT IDNCT06229470

SponsorSaluda Medical Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-28

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