RecruitingNCT05704751

EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients

Sponsor

Barts & The London NHS Trust

Enrollment

20 participants

Start Date

Oct 27, 2023

Study Type

OBSERVATIONAL

Conditions

Spinal Cord Stimulation Back Pain Lower Back Chronic

Summary

This study is designed to evaluate the feasibility of using intra-operative ECAP and Late-Response (LR) recordings for confirmation of activating the neuronal target of the dorsal column in a single-stage SCS lead placement procedure. The collected ECAP and LR data will be analysed post-hoc to further evaluate its utility for determining the laterality of lead placement with respect to the physiologic midline of the dorsal column.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

Be 18-75 years of age or older at the time of enrolment.
Symptoms of chronic predominant back pain for at least 6-months, with a minimum pain intensity of 5/10 in the primary pain area on VAS pain intensity questionnaire.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written inform consent in English.
Be willing and capable of giving informed consent.
Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria9

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, 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.
\. Subjects with chronic alcohol abuse or currently in rehabilitation. 4. Be benefitting within from an interventional procedure and/or surgery to treat chronic pain (Subjects should be enrolled at least 30 days from last benefit).
\. Have prior experience with SCS. 6. Have an existing drug pump and/or another active implantable device such as a pacemaker.
\. Have a condition currently requiring or likely to require the use of diathermy.
\. Have an active systemic or local infection at the anticipated needle entry site.
\. Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
\. Are currently nursing (if female).
\. Be concomitantly participating in another clinical study.

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