Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
CompletedNot applicableNCT04909593
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study
- Conditions
- Chronic Pain
- Intractable Pain
- Low Back Pain
- Pain, Neuropathic
- Pain, Back
- Interventions
- Sponsor
- Boston Scientific Corporation
- Start date
- 2021-05-24
- Primary completion
- 2022-11-22
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04909593