Spinal Cord Stimulation Trial to Permanent Prediction
United States28 participantsStarted 2021-05-27
Plain-language summary
Spinal Cord Stimulation Trial to Permanent Prediction is a prospective, longitudinal, multi-center, non-randomized, multi-arm, open-label, clinical feasibility study designed to investigate whether objective data collected from chronic pain patients is predictive of subjective patient-reported outcomes and of adjustments to patient programming parameters.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must provide written informed consent prior to any clinical investigation-related procedure.
✓. Subject is at least 18 years of age or older at the time of enrollment.
✓. Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable pain at least 7 days after enrollment and commencement of the baseline data collection period.
✓. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 3 days.
✓. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
✓. Subject is willing to cooperate with the study requirements including completion of all office visits.
✓. Subject agrees to wear the wearable sensing devices (Anne™ patch, Anne™ limb unit, Apple watch®, and Oura™ Ring).
✓. Subject agrees to answer questionnaires regularly for the duration of the study.
Exclusion criteria
✕. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
✕. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
✕. Subject is part of a vulnerable population.
✕
What they're measuring
1
Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
✕. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus.
✕. Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain.
✕. Subject has already participated in a SCS trial period before enrolling in the study.
✕. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.