Chronic Pain
Conditions
Keywords
ABT-CIP-10408, Spinal cord stimulation (SCS) systems, Neuromodulation system, Permanent Prediction
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.
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.
Interventions
DEVICEAbbott 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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period | Up to 6 months post-permanent implant | 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. |
Countries
United States
Contacts
STUDY_DIRECTORDavid M Page
Abbott Neuromodulation
Participant flow
Recruitment details
A total of 28 subjects at 7 clinical sites. Subjects were enrolled during the period of May 2021- October 2022. The last subject was enrolled on October 5, 2022. Subjects were followed from their baseline visit up to 6-months post permanent implant.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13.15 |
| Back Pain (No Surgery) | 5 Participants |
| Chronic Post-Operative Pain | 3 Participants |
| CRPS I | 1 Participants |
| Failed Back Surgery Syndrome | 10 Participants |
| Other (Lumbar Stenosis) | 1 Participants |
| Peripheral Neuropathy | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized White or Caucasian | 25 Participants |
| Radiculopathy | 6 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 3 / 28 |
Outcome results
None listed