Chronic Pain, Neuropathic Pain, Persistent Spinal Pain Syndrome Type 2
Conditions
Brief summary
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
Detailed description
The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients' sensation.
Interventions
DEVICEECAP-controlled, closed-loop SCS
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Sponsors
Karel Hanssens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Subject is willing and capable of giving informed consent.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with change in stimulation sensation | 6-months | Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS | Baseline, 3-months, 6-months, 12-months post-implant | 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. |
| Number of participants with reduced pain distribution | Baseline, 3-months, 6-months and 12-months post-implant | Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain. |
| Paraesthesia mapping | 3-months, 6-months and 12-months post-implant | Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia. |
Countries
Belgium
Contacts
Primary ContactKarel Hanssens, Dr.
Outcome results
None listed