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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246526
• Other study ID #: ULTRA Protocol 1.0
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Saint Francis Hospital
• Contact: Amy Young, RN BSN DMPNA
• Phone: 304-347-6144
• Email: amelia.young3[@]wvumedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain
• Pain

Intervention

Device:
• Evoke
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.

Locations

Country	Name	City	State
United States	The Spine and Nerve Center of Saint Francis Hospital	Charleston	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Saint Francis Hospital	Saluda Medical Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS - Visual Analog Scale		Baseline to 12 months
Secondary	PROMIS-29		Baseline to 12 months