ECAP-guided spinal cord stimulator lead placement and programming for chronic lower back pain
EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
We will see if using intra-operative ECAP and late-response recordings to guide spinal cord stimulator lead placement and programming can reduce chronic lower back pain in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05704751 on ClinicalTrials.gov |
What this trial studies
This observational study collects intra-operative evoked compound action potential (ECAP) and late-response (LR) recordings during a single-stage spinal cord stimulator (SCS) lead placement procedure. The recordings will be analyzed post-hoc to determine whether they confirm activation of the dorsal column target and help identify the physiologic midline for lead laterality. Pain intensity in the primary targeted area will be measured using the Visual Analogue Scale (VAS) at baseline and again at 3 months to look for change. The work is positioned in the context of emerging closed-loop/ECAP-guided SCS approaches aimed at improving targeting and durability of pain relief compared with conventional open-loop stimulation.
Who should consider this trial
Good fit: Adults 18–75 with predominant chronic lower back pain for at least 6 months, a baseline VAS pain score of 5/10 or higher, and who are medically suitable for spinal cord stimulator implantation are ideal candidates.
Not a fit: Patients with significant pain in other untreated areas, medical conditions that would confound pain reporting, inability to undergo surgery, or inability to read and consent in English may not benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this approach could improve accuracy of lead placement and lead to better, more durable pain relief for people with chronic lower back pain.
How similar studies have performed: Closed-loop and ECAP-guided spinal cord stimulation are emerging approaches that have shown promising results in some studies but remain relatively novel, especially for primarily back pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be 18-75 years of age or older at the time of enrolment. 2. 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. 3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician. 4. 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. 5. Be willing and capable of giving informed consent. 6. Be willing and able to comply with study-related requirements, procedures, and visits. Exclusion Criteria: 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. 2\. 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. 3\. 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). 5\. Have prior experience with SCS. 6. Have an existing drug pump and/or another active implantable device such as a pacemaker. 7\. Have a condition currently requiring or likely to require the use of diathermy. 8\. Have an active systemic or local infection at the anticipated needle entry site. 9\. 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). 10\. Are currently nursing (if female). 11\. Be concomitantly participating in another clinical study.
Where this trial is running
London
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Serge Nikolic
- Email: s.nikolic@nhs.net
- Phone: 020 3 765576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.