Chronic PainSCS T2PNCT05659836
Spinal Cord Stimulation Trial to Permanent Prediction
An observational study of Chronic Pain, run by Abbott Medical Devices at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 May 2021to 15 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Chronic Pain Specialty Clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- Subject is immunocompromised.
- Subject has history of cancer requiring active treatment in the last 12 months.
- Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection.
- Subject has life expectancy of less than 6 months.
- Subject is involved in an injury claim under current litigation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
iSpine Clinics
Burnsville, Minnesota, 55337
Coastal Pain & Spinal Diagnostics
Carlsbad, California, 92009
Goodman Campbell Brain & Spine
Carmel, Indiana, 46032
St. Louis Pain Consultants
Chesterfield, Missouri, 63017
The Orthopedic Institute
Gainesville, Florida, 32607
Expert Pain
Houston, Texas, 77079
Pacific Research Institute
Santa Rosa, California, 95403
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring)
- Keywords
- ABT-CIP-10408, Spinal cord stimulation (SCS) systems, Neuromodulation system, Permanent Prediction
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months post-permanent implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start27 May 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M Page, Study director, Abbott Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659836
- Sponsor's protocol ID
- ABT-CIP-10408
- Acronym
- SCS T2P
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2022
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation Trial to Permanent Prediction
- ClinicalTrials.gov ID
- NCT05659836
- Acronym / sponsor ID
- SCS T2P / ABT-CIP-10408
- Conditions
- Chronic Pain
- Keywords
- ABT-CIP-10408, Spinal cord stimulation (SCS) systems, Neuromodulation system, Permanent Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbott Spinal Cord Stimulation (SCS) Systems (Apple Watch® & Oura™ Ring) | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Chronic Pain Specialty Clinics
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
Primary outcome
Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Page study director
Abbott Neuromodulation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Abbott Medical Devices at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period (time frame: Up to 6 months post-permanent implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.