Spinal Cord Stimulation Trial to Permanent Prediction (SCS T2P)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)

Detailed Description

The study will enroll up to 60 subjects at 10 sites in the United States. Follow-up will continue for a period of 6 months post-trial for subjects who choose not to receive a permanently-implanted system as well as 6 months post implant for subjects receiving a permanent implant.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Pain & Spinal Diagnostics
    • Santa Rosa, California, United States, 95403
      • Pacific Research Institute
  • Florida
    • Gainesville, Florida, United States, 32607
      • The Orthopedic Institute
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Goodman Campbell Brain & Spine
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • iSpine Clinics
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Louis Pain Consultants
  • Texas
    • Houston, Texas, United States, 77079
      • Expert Pain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at Chronic Pain Specialty Clinics

Description

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 enrollment and commencement of the baseline data collection period.
4. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 3 days.
5. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
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).
8. Subject agrees to answer questionnaires regularly for the duration of the study.

Exclusion Criteria:

1. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
3. Subject is part of a vulnerable population.
4. 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.
5. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus.
6. 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.
7. Subject has already participated in a SCS trial period before enrolling in the study.
8. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
9. Subject has a skin condition that could be exacerbated by use of the adhesive Anne™ sensor or the other wearables (e.g. skin allergy to adhesives, metals, plastics, hydrogels), as determined by the investigator.
10. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
11. Subject has tremors (e.g. Parkinson's disease or Familial tremors).
12. Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device.
13. Subject is bedridden.
14. Subject has evidence of an active disruptive psychological or psychiatric disorder or social condition as determined by the investigator.
15. Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator.
16. Subject is immunocompromised.
17. Subject has history of cancer requiring active treatment in the last 12 months.
18. Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection.
19. Subject has life expectancy of less than 6 months.
20. Subject is involved in an injury claim under current litigation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring); Patients were implanted with Abbott spinal cord stimulation (SCS) systems (both trial and permanently implanted systems) and were provided with wearable sensors and mobile-based software with Apple Watch® and Oura Ring™ devices. Compliance with the devices was pooled across both the study arms of the patients, while digital survey compliance was analyzed separately for the sensing arm (MyPath Survey) and the coaching arm (MyPal Survey), reflecting the use of different survey applications in each arm of the patients.

Device: Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring); Patients were implanted with Abbott spinal cord stimulation (SCS) systems (both trial and permanently implanted systems) and were provided with wearable sensors and mobile-based software with Apple Watch® and Oura Ring™ devices. Compliance with the devices was pooled across both the study arms of the patients, while digital survey compliance was analyzed separately for the sensing arm (MyPath Survey) and the coaching arm (MyPal Survey), reflecting the use of different survey applications in each arm of the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period	This exploratory feasibility study seeks to determine whether wearable devices and digital surveys can be used to consistently monitor outcomes from chronic pain patients receiving implanted SCS therapy.	Up to 6 months post-permanent implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: David M Page, Abbott Neuromodulation

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ABT-CIP-10408; Spinal cord stimulation (SCS) systems; Neuromodulation system; Permanent Prediction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Drug Therapy; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Drug Delivery Systems; Spinal Cord Stimulation
• Other Study ID Numbers: ABT-CIP-10408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No