EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBarts & The London NHS Trust
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- spinal cord stimulation
Treatment groups
No treatment groups listed
Locations
1Barts Health NHS TrustEC1A 4NP, London United Kingdom
Sponsors and collaborators
Barts & The London NHS Trust
Lead sponsor
Source ClinicalTrials.gov