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

NCT05704751 | Recruiting FDA Device

• 1 other identifier: 322831
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Back Pain Lower Back Chronic; Spinal Cord Stimulation

Keywords

closed loop; spinal cord stimulation; chronic back pain

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline

• 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.

  Baseline and 3 months

• 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.

  Baseline, 3 month and 6 months

• 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.

  Baseline, 3, 6 and 12 months

Secondary Outcomes (9)

• Pain Symptoms map.

  Baseline

• Pain Symptoms map.

  Baseline and 3 months

• Pain Symptoms map.

  Baseline and 6 months

• Pain Symptoms map.

  Baseline and 12 months

• Paraesthesia coverage dermatomal map for final programming settings.

  3, 6 and 12 months

Interventions

spinal cord stimulation DEVICE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic predominant back as deemed suitable for SCS treatment

You may qualify if:

• 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.
• Be willing and capable of giving informed consent.
• Be willing and able to comply with study-related requirements, procedures, and visits.

You may not qualify if:

• 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.
• \. 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.
• \. 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).
• \. Have prior experience with SCS. 6. Have an existing drug pump and/or another active implantable device such as a pacemaker.
• \. Have a condition currently requiring or likely to require the use of diathermy.
• \. Have an active systemic or local infection at the anticipated needle entry site.
• \. 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).
• \. Are currently nursing (if female).
• \. Be concomitantly participating in another clinical study.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Health NHS Trust

London, EC1A 4NP, United Kingdom

RECRUITING

MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Serge Nikolic

CONTACT

020 3 765576; s.nikolic@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 30, 2023
• Study Start: October 27, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)