EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients

Launched by BARTS & THE LONDON NHS TRUST · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial, called EVOKE, is looking at a new way to help patients with chronic lower back pain through a procedure called spinal cord stimulation (SCS). The goal of the study is to see if a specific technique can help doctors place the SCS device more accurately during surgery. This technique involves recording signals from the spinal cord to make sure the device is positioned correctly. The researchers hope that by using these recordings, they can improve the effectiveness of the treatment for patients suffering from persistent back pain.

To be eligible for the trial, participants need to be between 18 and 75 years old and have been experiencing back pain for at least six months, with a pain level of 5 out of 10 or higher. They should also be suitable candidates for the surgery based on their doctor’s judgment. Participants will need to be able to understand and sign consent forms in English and follow study procedures. It’s important to note that individuals with certain medical conditions, previous experience with SCS, or those currently pregnant or nursing cannot participate. If you join the study, you can expect to undergo a surgical procedure and provide information about your pain and overall experience during the trial.

Gender

ALL

Eligibility 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.