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The purpose of the study is to gather clinical information on subjects' experiences with and without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).
This study is a multi-center, prospective, open-label, randomized, crossover study that is designed to gather clinical information on subjects' experiences with the use of the new feature of the RestoreSensor implantable neurostimulator. Current spinal cord stimulators for chronic intractable pain stimulate targeted nerves along the spine using electrical impulses. The stimulation interferes with the transmission of pain signals to the brain replacing painful sensations with a tingling sensation called paresthesia. Variation in the intensity of neurostimulation with body position is a challenge for some patients implanted with conventional spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. Patients need to manually adjust their stimulation using the patient programmer to maintain their comfort level during position changes. The AdaptiveStim feature of the RestoreSensor neurostimulator was developed to address this challenge by improving pain relief and/or convenience relative to manual programming adjustments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6-week AdaptiveStim followed by 6-week manual programming | Other |
| |
| 6-week manual followed by 6-week AdaptiveStim programming | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RestoreSensor Neurostimulation System | Device | Adjustments to stimulation settings are automatic when the AdaptiveStim feature of the device is turned "ON" and manual when the AdaptiveStim feature of the device is turned "OFF". |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm | After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective. | 16 weeks post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming | The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded "much worse pain relief with AdaptiveStim" or "somewhat worse pain relief with AdaptiveStim". |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22270733 | Derived | Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012 Jan-Feb;15(1):1-12. |
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Among the 79 subjects enrolled into the study, there were 3 subjects discontinued prior to implantation. The reasons for discontinuations were withdrawal of consent (n = 2) and eligibility criteria not met (n = 1). A total of 76 subjects were implanted and randomized at 4 weeks post implant.
The sponsor activated 10 study centers after the study protocol was approved by FDA in March 2010. The overall recruitment for study subjects lasted less than 5 months, with the first enrollment on April 20, 2010, and last enrollment on September 3, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 6-week AdaptiveStim Followed by 6-week Manual Programming | Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks. |
| FG001 | 6-week Manual Followed by 6-week AdaptiveStim Programming | Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I (First 6 Weeks) |
|
| |||||||||||||||||||||
| Period II (Second 6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6-week AdaptiveStim Followed by 6-week Manual Programming | Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks. |
| BG001 | 6-week Manual Followed by 6-week AdaptiveStim Programming |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm | After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective. | The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective. No imputation method was used for 71 subjects included in the completed case analysis. | Posted | Number | percentage of participants | 16 weeks post-implant |
|
The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
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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 | Overall Adverse Events | Overall adverse events were reported. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Undesirable change in stimulation | General disorders | MedDRA (8.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Sun, Senior Clinical Research Manager | Neuromodulation Emerging Therapy Clinical Research, Medtronic, Inc | 763-526-8098 | mark.sun@medtronic.com |
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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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| 16 weeks post-implant |
| Manual Adjustments Presented as Button Presses | The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared. | Baseline, 10 weeks and 16 weeks post-implant |
| NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant | The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine," accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits. | Baseline, 10 weeks and 16 weeks post-implant |
| Oceanside |
| California |
| 92056 |
| United States |
| Edina | Minnesota | 55435 | United States |
| Las Vegas | Nevada | 89149 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| Eugene | Oregon | 97401 | United States |
| Dallas | Texas | 75237 | United States |
| San Antonio | Texas | 78229 | United States |
| San Antonio | Texas | 78258 | United States |
| Salt Lake City | Utah | 84106 | United States |
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| NOT COMPLETED |
|
Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| average Numeric Pain Rating Scale (NPRS) | NPRS is a 11-point scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine." For average NPRS, study subjects were instructed to "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." | Mean | Standard Deviation | units on a scale |
|
| worst Numeric Pain Rating Scale (NPRS) | NPRS is a 11-point scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine." For worst NRPS, study subjects were instructed to "Please rate your pain by indicating the number that best describes your worst pain in the last 24 hours." | Mean | Standard Deviation | units on a scale |
|
| Title |
|---|
| Description |
|---|
| OG000 | 6-week AdaptiveStim Followed by 6-week Manual Programming | Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks. |
| OG001 | 6-week Manual Followed by 6-week AdaptiveStim Programming | Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks. |
|
|
|
| Secondary | Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming | The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded "much worse pain relief with AdaptiveStim" or "somewhat worse pain relief with AdaptiveStim". | A total of 71 subjects with completed data were included in this analysis. | Posted | Number | percentage of participants | 16 weeks post-implant |
|
|
|
|
| Secondary | Manual Adjustments Presented as Button Presses | The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared. | Subjects with manual adjustments data from patient programmer were included in the analysis. | Posted | Mean | Standard Deviation | Button presses per day | Baseline, 10 weeks and 16 weeks post-implant |
|
|
|
|
| Secondary | NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant | The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine," accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits. | 69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 10 weeks and 16 weeks post-implant |
|
|
|
|
| 8 |
| 76 |
| 53 |
| 76 |
| Implant site infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Change in sensation of stimulation | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Implant site irritation | General disorders | MedDRA (8.0) | Systematic Assessment |
|
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| Mean Difference (Final Values) |
| 1.50 |
| Standard Deviation |
| 2.04 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |