Actively Recruiting
Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation Therapy
Led by Karel Hanssens · Updated on 2025-01-15
12
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe patients with chronic pain who have received an EvokeTM spinal cord stimulator. The study focuses on how different settings affect nerve activation and how these changes influence patients' sensation. It is a prospective, single-center observational study evaluating the accuracy of neuronal activation and patient experience with closed-loop spinal cord stimulation therapy. Participants use a device called ECAP-controlled, closed-loop spinal cord stimulation (SCS), which measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to keep ECAP amplitude consistent. The study observes how these device settings impact stimulation sensations and pain over time. During the study, participants are monitored at various time points including baseline, 3 months, 6 months, and 12 months after implant. Assessments include pain ratings on a numeric scale, mapping of paraesthesia (tingling sensations), and tracking changes in pain distribution. The main outcome is the number of participants experiencing changes in stimulation sensation at 6 months. The study continues through to December 2029, with ongoing follow-up to capture these effects.
CONDITIONS
Brief 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 spinal cord stimulation trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
- Subject has a minimum pain intensity of 5 out of 10 on the numeric rating scale at baseline.
- Subject is 18 years old or older.
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months post-implant
Participants who have received the Evoke spinal cord stimulator are monitored to assess neuronal activation accuracy and stimulation sensation with different device settings.
Visits at baseline, 3 months, 6 months, and 12 months post-implant
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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