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This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord stimulation | Experimental | Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programming | Device | Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort | Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable" | An estimated average of 7 days post temporary trial procedure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain, M.S. | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Pain Management, Inc. | Ventura | California | 93003 | United States | ||
| PCPMG Clinical Research Unit, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38361978 | Derived | Zhu C, Esteller R, Block J, Lechleiter K, Frey R, Moffitt MA. Exploratory evaluation of spinal cord stimulation with dynamic pulse patterns: a promising approach to improve stimulation sensation, coverage of pain areas, and expected pain relief. Front Pain Res (Lausanne). 2024 Jan 31;4:1339892. doi: 10.3389/fpain.2023.1339892. eCollection 2023. |
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35 subjects were enrolled in and started the study. 2 were withdrawn prior to the Programming Visit. 33 started the Programming Visit and 32 completed the study. Statistically relevant conclusions cannot be made from this small sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation | Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulation | Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial |
| 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 Comfort | Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable" | 32 subjects completing the Programming Visit | Posted | Count of Participants | Participants | An estimated average of 7 days post temporary trial procedure |
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Adverse events reported from enrollment to end of study (up to 15 days)
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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 | Spinal Cord Stimulation | Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Sciences and Scientific Communication | Boston Scientific | 855-213-9890 | BSNClinicalTrials@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2019 | Dec 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Greenville |
| South Carolina |
| 29601 |
| United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Work Status | Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status. | Number | participants |
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| Participants |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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