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The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.
The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label treatment | Other | Spinal Cord Stimulation (SCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation (SCS) | Device | SCS programming options |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | From baseline to 3 months post device activation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change | Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | From baseline to 3 months post device activation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| OPTIONS Clinical Research Study Team | Medtronic Implantable Therapies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Pain Consultants-North Scottsdale | Scottsdale | Arizona | 85254 | United States | ||
| Synovation Medical Group |
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All enrolled subjects will undergo a Spinal Cord Stimulation device trial that includes an intraoperative programming trial. Subjects experiencing a positive response (improvement in average overall pain relief) during the trial will move forward with a permanent implant. Those not reporting a positive response will be exited from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Treatment | Spinal Cord Stimulation (SCS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| ||||||||||||||||||||||||
| Device Trial (HD Programming Trial) |
| |||||||||||||||||||||||||
| Successful Trial (≥50% Pain Relief) |
| |||||||||||||||||||||||||
| Implant to 3 Month Endpoint |
|
Implanted and Device Activated subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Treatment | Spinal Cord Stimulation (SCS) |
| 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 | Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 3 months post device activation |
|
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Adverse events were collected beginning at the device trialing procedure and throughout implant and the 3 month activation phase.
The sample for adverse event reporting is the 48 subjects who initiated the device trialing procedure (44 subjects started the HD programming trial). Device, therapy, and/or procedure-related adverse events were collected. Adverse events that were documented as the reason for discontinuation were also collected regardless of etiology.
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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 | Device: Neurostimulator | RestoreSensor SureScan MRI Rechargeable Neurostimulator RestoreSensor SureScan MRI Rechargeable Neurostimulator: RestoreSensor SureScan MRI Rechargeable Neurostimulator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Pain in Bilateral Feet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia (uncomfortable sensation) | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Berrier | Medtronic Implantable Therapies | 1-800-633-8766 | medtronicneurotrials@medtronic.com |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D059350 | Chronic Pain |
| D055111 | Failed Back Surgery Syndrome |
| 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 |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| From baseline to 3 months post device activation |
| Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | From baseline to 3 months post device activation |
| Chula Vista |
| California |
| 91914 |
| United States |
| Center for Interventional Pain Spine | Wilmington | Delaware | 19803 | United States |
| Pain Care LLC | Stockbridge | Georgia | 30281 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61701 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106-1716 | United States |
| St. Luke's Neurosurgical Associates | Bethlehem | Pennsylvania | 18018 | United States |
| Precision Spine Care | Tyler | Texas | 75701-4262 | United States |
| Swedish Pain Services | Seattle | Washington | 98122 | United States |
| Northwest Pain Care | Spokane | Washington | 99201 | United States |
| Insurance issue |
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| Lost to Follow-up |
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| Study closure |
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| Adverse Event |
|
| Protocol Violation |
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| Inability to implant system |
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| Unable to be programmed |
|
|
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Average Overall Pain | Self reported daily average overall pain score 5 days prior to baseline. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Patient Global Impression of Change | Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference). | Posted | Count of Participants | Participants | From baseline to 3 months post device activation |
|
|
|
| Other Pre-specified | Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 3 months post device activation |
|
|
|
| Other Pre-specified | Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 3 months post device activation |
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 12 |
| 48 |
|
| Implant site warmth | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
The disclosure restrictions on the PI allow for the sponsor to review results communications prior to public release and to embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to sponsor for review. The sponsor is also allowed to require changes for technical correctness and to protect confidential information, copyrightable or patentable material; and when reasonably requested, extend the embargo up to an additional 90 days.
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |
| 4 - Somewhat better |
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| 3 - A little better |
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| 2 - Almost the same |
|
| 1 - No change (or worse) |
|