Trial Outcomes & Findings for Spinal Cord Stimulation Trial to Permanent Prediction (NCT NCT05659836)
NCT ID: NCT05659836
Last Updated: 2026-04-30
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
28 participants
Primary outcome timeframe
Up to 6 months post-permanent implant
Results posted on
2026-04-30
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
28
|
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Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
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10
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Chose not to get an SCS trial
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3
|
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Overall Study
Unable to operate wearable devices
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1
|
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Overall Study
Chose not to progress to permanent implant
|
2
|
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Overall Study
Death
|
1
|
|
Overall Study
Voluntary withdrawal, no reasons disclosed
|
2
|
|
Overall Study
Challenges following up with patient
|
1
|
Baseline Characteristics
Spinal Cord Stimulation Trial to Permanent Prediction
Baseline characteristics by cohort
| Measure |
Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)
n=28 Participants
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.
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|---|---|
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Age, Continuous
|
58 years
STANDARD_DEVIATION 13.15 • n=14 Participants
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|
Sex: Female, Male
Female
|
16 Participants
n=14 Participants
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|
Sex: Female, Male
Male
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12 Participants
n=14 Participants
|
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Race/Ethnicity, Customized
White or Caucasian
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25 Participants
n=14 Participants
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Race/Ethnicity, Customized
Black or African American
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3 Participants
n=14 Participants
|
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Failed Back Surgery Syndrome
|
10 Participants
n=14 Participants
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Radiculopathy
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6 Participants
n=14 Participants
|
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Chronic Post-Operative Pain
|
3 Participants
n=14 Participants
|
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CRPS I
|
1 Participants
n=14 Participants
|
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Back Pain (No Surgery)
|
5 Participants
n=14 Participants
|
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Peripheral Neuropathy
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2 Participants
n=14 Participants
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Other (Lumbar Stenosis)
|
1 Participants
n=14 Participants
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PRIMARY outcome
Timeframe: Up to 6 months post-permanent implantPopulation: Subjects who underwent an SCS trial and provided digital survey and wearable sensor data 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.
Outcome measures
| Measure |
Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)
n=18 Participants
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.
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|---|---|
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Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
Apple Watch
|
58.2 percentage of days
Interval 32.0 to 71.3
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Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
Oura™ Sleep
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36.0 percentage of days
Interval 11.4 to 53.2
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|
Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
Oura™ Activity
|
57.0 percentage of days
Interval 24.7 to 70.6
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Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
MyPath Survey
|
44.9 percentage of days
Interval 13.6 to 55.3
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|
Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
MyPal Survey
|
32.0 percentage of days
Interval 3.9 to 46.9
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Adverse Events
Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)
n=28 participants at risk
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.
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|---|---|
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Nervous system disorders
Seizure
|
3.6%
1/28 • Up to 6-months post permanent implant.
|
|
Cardiac disorders
Myocardial Infarction
|
3.6%
1/28 • Up to 6-months post permanent implant.
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|
Infections and infestations
COVID-19 Hospitalization
|
3.6%
1/28 • Up to 6-months post permanent implant.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall be sent draft results 60 days before submission. Sponsor has 60 days after receipt to return comments. In addition, Sponsor may request an extra 60-day delay to secure patent protection.
- Publication restrictions are in place
Restriction type: OTHER