Chronic Pain Clinical Trial
— AIMOfficial title:
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study
NCT number | NCT04909593 |
Other study ID # | A4091 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | July 2024 |
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).
Status | Recruiting |
Enrollment | 25 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | PCPMG Clinical Research Unit, LLC | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perception Threshold | Percent change in perception threshold from sitting to standing | up to 15 days post-screening |
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