Status:
COMPLETED
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Pain
Intractable Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).
Eligibility Criteria
Inclusion
- Key
- Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).
- 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.
- Key
Exclusion
- Subject meets any contraindication in BSC neurostimulation system local DFU.
- 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.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04909593
Start Date
May 24 2021
End Date
November 22 2022
Last Update
December 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States, 29601