Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarel Hanssens
About this trial
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ≥ 18 years old.
Subject is not pregnant or nursing.
Disqualifiers
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.
Trial population
Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ECAP-controlled, closed-loop SCS
DeviceSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of participants with change in stimulation sensation
Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.
Time frame
6-monthsSecondary outcomes
1
NRS
The numeric rating scale (NRS) is a pain screening tool. It is used to assess pain severity at that moment in time using a 0-10 scale. Zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Time frame
Baseline, 3-months, 6-months, 12-months post-implant2
Number of participants with reduced pain distribution
Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain.
Time frame
Baseline, 3-months, 6-months and 12-months post-implant3
Paraesthesia mapping
Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia.
Time frame
3-months, 6-months and 12-months post-implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karel Hanssens
Lead sponsor
AZ Delta
Sponsor institution
Source ClinicalTrials.gov