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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at Chronic Pain Specialty Clinics
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| Name | Affiliation | Role |
|---|---|---|
| David M Page | Abbott Neuromodulation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Pain & Spinal Diagnostics | Carlsbad | California | 92009 | United States | ||
| Pacific Research Institute |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects who underwent an SCS trial and provided digital survey and wearable sensor data post-permanent implant. | Posted | Median | Inter-Quartile Range | percentage of days | Up to 6 months post-permanent implant |
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Up to 6-months post permanent implant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David M. Page, PhD | Abbott Laboratories | 678-951-2075 | David.page1@abbott.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2021 | Oct 30, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| Santa Rosa |
| California |
| 95403 |
| United States |
| The Orthopedic Institute | Gainesville | Florida | 32607 | United States |
| Goodman Campbell Brain & Spine | Carmel | Indiana | 46032 | United States |
| iSpine Clinics | Burnsville | Minnesota | 55337 | United States |
| St. Louis Pain Consultants | Chesterfield | Missouri | 63017 | United States |
| Expert Pain | Houston | Texas | 77079 | United States |
| Death |
|
| Voluntary withdrawal, no reasons disclosed |
|
| Challenges following up with patient |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Failed Back Surgery Syndrome | Count of Participants | Participants |
|
| Radiculopathy | Count of Participants | Participants |
|
| Chronic Post-Operative Pain | Count of Participants | Participants |
|
| CRPS I | Determination of CRPS I (also known as Reflex Sympathetic Dystrophy) was based on patient self-report and is distinguished from CRPS II based on no knowledge of a specific nerve injury leading to the condition. Within the CRPS I category, no stages or grades were assessed. | Count of Participants | Participants |
|
| Back Pain (No Surgery) | Count of Participants | Participants |
|
| Peripheral Neuropathy | Count of Participants | Participants |
|
| Other (Lumbar Stenosis) | Count of Participants | Participants |
|
|
|
| 1 |
| 28 |
| 3 |
| 28 |
| 0 |
| 28 |
| Myocardial Infarction | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
|
| COVID-19 Hospitalization | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
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.
| D004358 |
| Drug Therapy |