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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with chronic predominant back as deemed suitable for SCS treatment
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
spinal cord stimulation
DeviceEVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Visual Analogue Scale (VAS), 0-100 where 0 is no pain and 100 is worst pain.
Evaluate average pain relief using the Visual Analogue Scale (VAS).
Time frame
Baseline2
Difference in Visual Analogue Scale (VAS), 0-100 where 0 is no pain and 100 is worst pain.
Evaluate average pain relief using the Visual Analogue Scale (VAS). Percentage change in average pain intensity in the primary region of pain on the VAS.
Time frame
Baseline and 3 months3
Difference in Visual Analogue Scale (VAS), 0-100 where 0 is no pain and 100 is worst pain.
Evaluate average pain relief using the Visual Analogue Scale (VAS).Percentage change in average pain intensity in the primary region of pain on the VAS.
Time frame
Baseline, 3 month and 6 months4
Difference Visual Analogue Scale (VAS), 0-100 where 0 is no pain and 100 is worst pain.
Evaluate average pain relief using the Visual Analogue Scale (VAS).Percentage change in average pain intensity in the primary region of pain on the VAS.
Time frame
Baseline, 3, 6 and 12 monthsSecondary outcomes
1
Pain Symptoms map.
Mapping areas of pain
Time frame
Baseline2
Pain Symptoms map.
Mapping areas of pain
Time frame
Baseline and 3 months3
Pain Symptoms map.
Mapping areas of pain
Time frame
Baseline and 6 months4
Pain Symptoms map.
Mapping areas of pain
Time frame
Baseline and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov