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

Recruiting now

Conditions studied: Back Pain Lower Back Chronic, Spinal Cord Stimulation

In brief

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.

Key facts

Study ID

NCT05704751

Run by

Barts & The London NHS Trust

People needed

20

Starts

2023-10-27

Expected to finish

2026-04-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barts Health NHS Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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