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Stopped due to a business decision
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The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bipolar then alternative field shape stimulation | Active Comparator | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days |
|
| Alternative then bipolar field shape stimulation | Experimental | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System | Device | Spinal cord stimulation for the management of chronic neuropathic pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preferred Field Shape | Number of participants preferring bipolar field shape and alternative field shape | 42 days post randomization |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Eldabe, MD | James Cook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bartholomew's Hospital | London | EC1A 7Be | United Kingdom | |||
| James Cook University Hospital |
16 subjects were enrolled in the study. 10 were withdrawn prior to randomization. 6 were randomized. Statistically relevant conclusions cannot be made from this small sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bipolar Then Alternative Field Shape Stimulation | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days |
| FG001 | Alternative Then Bipolar Field Shape Stimulation | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field stimulation for 21 days, then bipolar shape stimulation for 21 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention, 21 Days |
| |||||||||||||
| Second Intervention, 21 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bipolar Then Alternative Field Shape Stimulation | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days |
| BG001 |
| 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 | Patient Preferred Field Shape | Number of participants preferring bipolar field shape and alternative field shape | Posted | Count of Participants | Participants | 42 days post randomization |
|
Adverse events reported from randomization to 42 days post randomization
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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 | Bipolar Field Shape Stimulation | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar field shape stimulation for 21 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Sciences and Scientific Communication | Boston Scientific | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2017 | Sep 3, 2019 | Prot_000.pdf |
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| Middlesbrough |
| TS4 3BW |
| United Kingdom |
| NOT COMPLETED |
|
| Alternative Then Bipolar Field Shape Stimulation |
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Alternative Field Shape Stimulation | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days | 0 | 6 | 0 | 6 | 0 | 6 |
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