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

Launched by SALUDA MEDICAL PTY LTD · Jan 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new way to help manage chronic pain, specifically pain in the back and limbs, using a device called the Evoke System. The study aims to see if measurements of nerve activity can help doctors better tailor treatment for patients experiencing severe, ongoing pain that hasn’t responded to other treatments. Participants will be individuals who are planning to undergo a temporary trial with this system and have significant pain levels, specifically a score of 6 or higher on a scale used to measure pain.

To be eligible for this trial, participants must be between the ages of 18 and 74, able to read and understand English, and willing to provide informed consent. This means they should be ready to learn about the study and agree to take part. The trial is currently recruiting, so those who fit the criteria can expect to undergo a series of assessments and visits related to their pain management. The goal is to find out if this new method can improve the way chronic pain is treated, offering hope for better relief for those struggling with it.

Gender

ALL

Eligibility criteria

• 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