Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

NCT06246526 | Active Not Recruiting FDA Device

• 1 other identifier: ULTRA Protocol 1.0
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

Conditions

Pain; Chronic Pain; Neuropathic Pain

Keywords

Saluda; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• VAS - Visual Analog Scale

  Baseline to 12 months

Secondary Outcomes (1)

• PROMIS-29

  Baseline to 12 months

Interventions

Evoke DEVICE

The Saluda Medical Evoke® CL-SCS System (Evoke System). The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode.

Also known as: Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older at the time of enrollment.
• Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
• Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.
• Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
• 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:

• Subject is pregnant or nursing.
• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, 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.
• Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
• Have prior experience with SCS.
• Be concomitantly participating in another clinical study.

Sponsors & Collaborators

• Saint Francis Hospital: lead
• Saluda Medical Americas, Inc.: collaborator

Study Sites (1)

The Spine and Nerve Center of Saint Francis Hospital

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Neuralgia

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Timothy Deer, MD

  Spine and Nerve Center of Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 30, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)