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

S

Saluda Medical

Status

Enrolling

Conditions

Chronic Pain

Treatments

Device: Evoke Spinal Cord Stimulation (SCS) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06229470
D103977

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 1 patient group

ECAP-Controlled, Closed-Loop SCS
Experimental group
Description:
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Treatment:
Device: Evoke Spinal Cord Stimulation (SCS) System

Trial contacts and locations

22

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Central trial contact

Angela Leitner, MS

Data sourced from clinicaltrials.gov

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