Spinal Cord Stimulation Trial to Permanent Prediction

NCT05659836 | Completed Results

• 1 other identifier: ABT-CIP-10408
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Chronic Pain

Keywords

ABT-CIP-10408; Spinal cord stimulation (SCS) systems; Neuromodulation system; Permanent Prediction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring) DEVICE

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.

Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Chronic Pain Specialty Clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
• Subject has tremors (e.g. Parkinson's disease or Familial tremors).
• 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.
• Subject is bedridden.
• Subject has evidence of an active disruptive psychological or psychiatric disorder or social condition as determined by the investigator.
• Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

Coastal Pain & Spinal Diagnostics

Carlsbad, California, 92009, United States

Location

Pacific Research Institute

Santa Rosa, California, 95403, United States

Location

The Orthopedic Institute

Gainesville, Florida, 32607, United States

Location

Goodman Campbell Brain & Spine

Carmel, Indiana, 46032, United States

Location

iSpine Clinics

Burnsville, Minnesota, 55337, United States

Location

St. Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

Location

Expert Pain

Houston, Texas, 77079, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drug Therapy

Results Point of Contact

• Title: David M. Page, PhD
• Organization: Abbott Laboratories

David.page1@abbott.com

678-951-2075

Study Officials

• David M Page

  Abbott Neuromodulation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 21, 2022
• Study Start: May 27, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)