Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
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.
Study Type
OBSERVATIONAL
Enrollment
12
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
AZ Delta
Roeselare, Belgium
RECRUITINGNumber 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-months
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-implant
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-implant
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-implant
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