Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
NCT ID: NCT04909593
Last Updated: 2024-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2021-05-24
2022-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Spinal Cord Stimulation
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Spinal Cord Stimulation
Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
Interventions
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Spinal Cord Stimulation
Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject signed a valid, EC/IRB-approved informed consent form.
* Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.
* In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.
Exclusion Criteria
* Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
* Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
* Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Bloom Lyons
Role: STUDY_DIRECTOR
Boston Scientific Neuromodulation Corporation
Locations
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PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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A4091
Identifier Type: -
Identifier Source: org_study_id