Actively Recruiting
Assessment of Neuronal Activation Accuracy and Sensation in Patients with Closed-loop Spinal Cord Stimulation Therapy for Chronic Pain
Led by Karel Hanssens · Updated on 2025-01-15
12
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with chronic pain who have received an EvokeTM spinal cord stimulator. The study aims to evaluate how different nerve activation settings influence patients' sensations and the accuracy of neuronal activation with closed-loop spinal cord stimulation therapy. This is an observational, prospective, single-center study focusing on the effects of the device on stimulation sensations and nerve responses. Participants will use an ECAP-controlled, closed-loop spinal cord stimulation device that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to keep the ECAP amplitude consistent. The study follows patients who have already undergone the spinal cord stimulator implant and monitors their sensation changes over time. Participants will be assessed for changes in stimulation sensation over a 6-month period. Researchers will collect data on nerve activation accuracy and patient responses to therapy. The study involves follow-up visits where sensations and device performance are evaluated, helping to understand the therapy's impact on chronic pain management.
CONDITIONS
Official Title
Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
- Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
- Subject is 218 years old.
- Subject is not pregnant or nursing.
- Subject is willing and capable of giving informed consent.
You will not qualify if you...
- Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
- Subject is incapable of understanding or responding to the study questionnaires.
- Subject is incapable of understanding or operating the patient programmer handset.
AI-Screening
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Trial Site Locations
Total: 1 location
1
AZ Delta
Roeselare, Belgium, 8800
Actively Recruiting
Research Team
K
Karel Hanssens, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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