RECRUITING

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

Description

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.

Conditions

Chronic Pain
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Related Conditions:

Chronic Pain

Study Overview

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Study Details

Study overview

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.

A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.

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

Condition
Chronic Pain
Intervention / Treatment

-

Contacts and Locations

Lake Havasu City

Lakeside Spine and Pain, Lake Havasu City, Arizona, United States, 86403

Camarillo

Spanish Hills Interventional Pain Specialists, Camarillo, California, United States, 93010

La Mesa

Pain Consultants of San Diego, La Mesa, California, United States, 91942

Santa Rosa

Pacific Research Institute, Santa Rosa, California, United States, 94104

Walnut Creek

Boomerang Healthcare, Walnut Creek, California, United States, 94598

Greenwood Village

DBPS Research, Greenwood Village, Colorado, United States, 80111

Delray Beach

Pohlman Pain Associates, Delray Beach, Florida, United States, 33445

Jasper

Horizon Clinical Research, Jasper, Georgia, United States, 30143

Rockford

Rockford Pain Center, Rockford, Illinois, United States, 61107

Carmel

Goodman Campbell Brain and Spine, Carmel, Indiana, United States, 46032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * N/A

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Saluda Medical Pty Ltd,

Study Record Dates

2027-02-28