Abbott SCS Trial to Permanent Prediction Clinical Study

Study Purpose

• The purpose of this study is to collect a variety of objective data points from patients utilizing SCS and to learn which specific data points best identify the unique needs of each patient. This data should help physicians better assess the complete picture behind each patient’s day-to-day chronic pain journey. Eventually, this information may enable treatments to be further personalized to each patient’s unique needs.

Abbott SCS T2P Study: A prospective, longitudinal, multi-center, non-randomized, multi-arm, open-label, clinical feasibility study designed to investigate whether objective data (e.g. from wearable sensors and GPS location) collected from chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care (e.g. adjustments in programming of the SCS device).

• IRB Protocol #20211895
• Sponsor: Abbott Laboratories
• The study will enroll up to 60 subjects from up to 10 sites in the United States
• Physicians would like to have a more-complete picture of each patient’s unique day-to-day healthcare needs. The results of this study are expected to provide doctors with better guidance on how to fine-tune healthcare and treatments to address each patient’s evolving needs.

Requirements

In order to make this assessment, patients who enroll in this study will engage in the following investigational activities for 6 months:

• Respond to survey questions and interact daily on a mobile phone application
• Use wearable sensors during daily activities, including an Apple watch, Oura ring, and chest and extremity sensors
• Return for several scheduled clinical visits; specifically, at baseline, SCS trial start, SCS trial end, SCS implant, and 2, 4, and 6 months after SCS implant.

Can I Participate?

To be included in the study, you must meet these criteria (Inclusion Criteria):

1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
2. Subject is at least 18 years of age or older at the time of enrollment
3. Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable pain at least 7 days after study enrollment and commencement of the baseline data collection period.
4. Subject is scheduled for an Abbott neuromodulation system trial that has a duration of at least 3 days.
5. Subject has a baseline (with no stimulation) pain score of at least 6 out of 10.
6. Subject is willing to cooperate with the study requirements including completion of all office visits.
7. Subject agrees to wear the wearable sensing devices (Anne™ patch, Anne™ limb unit, Apple® watch, and Oura™ Ring) according to the schedule outlined in the protocol.
8. Subject agrees to answer questionnaires regularly for the duration of the study according to the schedule outlined in the protocol.

You may not be eligible for the study if you have any of these criteria (Exclusion Criteria):

1. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
2. Subject is pregnant or nursing or plans to become pregnant during the clinical investigation follow-up period.