Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2027-02-28

Brief Summary

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The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECAP-Controlled, Closed-Loop SCS

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.

Group Type EXPERIMENTAL

Evoke Spinal Cord Stimulation (SCS) System

Intervention Type DEVICE

A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.

Interventions

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Evoke Spinal Cord Stimulation (SCS) System

A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
* Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]).
* Back pain score ≥ 6 cm (VAS).
* Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
* Subject is not pregnant and not \<18 years of age.

Exclusion Criteria

* N/A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Corpus Christi, Texas, United States

Site Status RECRUITING

Victoria Pain and Rehabilitation Center

Victoria, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela Leitner, MS

Role: CONTACT

Phone: 651-208-4223

Email: [email protected]

Other Identifiers

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D103977

Identifier Type: -

Identifier Source: org_study_id

Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

ECAP-Controlled, Closed-Loop SCS

Evoke Spinal Cord Stimulation (SCS) System

Interventions

Evoke Spinal Cord Stimulation (SCS) System

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Saluda Medical Pty Ltd

Responsible Party

Locations

Lakeside Spine and Pain

Spanish Hills Interventional Pain Specialists

Pain Consultants of San Diego

Pacific Research Institute

Boomerang Healthcare

DBPS Research

Pohlman Pain Associates

Horizon Clinical Research

Rockford Pain Center

Goodman Campbell Brain and Spine

Metro Anesthesia & Pain Management

Restorative Pain Institute

Advanced Pain Institute

Spine and Joint Institute

Michigan Pain Specialists

Pain Clinic of Michigan

Tricity Research Center, LLC

Reno Tahoe Pain Associates

Garden State Pain and Orthopedics

Seaside Clinical Research Institute

Cleveland Clinic Foundation

Premier Pain Treatment Institute

Carolinas Center for Advanced Management of Pain

Institute of Precision Pain Medicine

Victoria Pain and Rehabilitation Center

Countries

Central Contacts

Angela Leitner, MS

Other Identifiers

D103977