Actively Recruiting
EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Led by Barts & The London NHS Trust · Updated on 2026-01-08
20
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 to 75 years old at the time of enrollment.
- Have chronic predominant back pain for at least 6 months with a minimum pain intensity of 5 out of 10 in the primary pain area.
- Be considered an appropriate candidate for the surgical procedures by the implanting physician.
- Be able to read, understand, and sign informed consent in English and complete English questionnaires.
- Be willing and able to give informed consent.
- Be willing and able to comply with all study requirements, procedures, and visits.
You will not qualify if you...
- Have a medical condition or pain in other areas not intended for treatment that could interfere with study procedures or pain reporting.
- Have an active disruptive psychological or psychiatric disorder affecting pain perception or treatment compliance.
- Have chronic alcohol abuse or currently be in rehabilitation.
- Have recently benefited from an interventional procedure or surgery for chronic pain (within 30 days).
- Have prior experience with spinal cord stimulation.
- Have an existing drug pump or other active implantable device like a pacemaker.
- Require or likely to require diathermy treatment.
- Have an active systemic or local infection at the needle entry site.
- Be pregnant (if female and sexually active, must use reliable birth control, be surgically sterile, or at least 2 years post-menopausal).
- Currently nursing (if female).
- Be participating in another clinical study concurrently.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Barts Health NHS Trust
London, United Kingdom, EC1A 4NP
Actively Recruiting
Research Team
S
Serge Nikolic
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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