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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of intra-operative Evoked Compound Action Potential (ECAP) and Late-Response (LR) recordings to confirm activation of the dorsal column neuronal target during a single-stage spinal cord stimulation (SCS) lead placement procedure in patients with chronic back pain. The study aims to analyze these recordings to better understand lead placement accuracy relative to the physiological midline of the dorsal column. The research also seeks to assess changes in pain intensity over a 3-month period using the Visual Analogue Scale (VAS). Participants will receive spinal cord stimulation through a device programmed using ECAP-based feedback. The study evaluates the overlap between the area of paraesthesia coverage and the primary pain region reported by patients. Following the initial lead placement and programming, patients will be monitored for up to 12 months. Data collection includes pain maps, stimulation settings, and neurophysiological characteristics at baseline, 3, 6, and 12 months post-activation. During the study, participants will complete questionnaires such as the PROMIS 29+2 Profile and VAS to measure pain intensity and quality of life. Researchers will track long-term treatment outcomes, patient satisfaction, and sleep quality. Safety and efficacy will be assessed through ongoing follow-up visits and data analysis to better understand the effectiveness of ECAP-controlled programming for chronic back pain management.
CONDITIONS
Brief 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 of age at enrolment
- Have chronic predominant back pain for at least 6 months
- Have a minimum pain intensity of 5 out of 10 in the primary pain area
- Be suitable for the required surgical procedures as judged by the implanting physician
- Be able to read, understand, and sign informed consent in English
- Be willing and able to comply with study requirements and visits
You will not qualify if you...
- Have pain or medical conditions in other areas not treated by spinal cord stimulation that could interfere with the study
- Have active psychological or psychiatric disorders affecting pain perception or treatment compliance
- Have chronic alcohol abuse or be in rehabilitation
- Have recently benefited from interventional procedures or surgery for pain (within 30 days)
- Have prior spinal cord stimulation experience
- Have an existing drug pump or other active implantable devices like a pacemaker
- Require or likely to require diathermy treatments
- Have active infections at the needle entry site
- Are pregnant, nursing, or not using reliable birth control if sexually active female
- Are currently participating in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a single-stage spinal cord stimulation lead placement procedure using ECAP and LR recordings to confirm activation of the neural target.
1 in-person surgical visit
Duration - 12 months
Participants receive closed-loop spinal cord stimulation programmed using objective neurophysiological feedback (ECAPs) to manage chronic back and/or leg pain.
Visits at baseline, 3 months, 6 months, and 12 months post-activation and initial programming
Duration - 12 months
Participants are followed to evaluate long-term clinical outcomes including pain relief, quality of life, satisfaction, and neurophysiological characteristics.
Visits at 3 months, 6 months, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Barts Health NHS Trust
London, United Kingdom, EC1A 4NP
Actively Recruiting
Research Team
S
Serge Nikolic
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here