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Clinical Trials/NCT04909593
NCT04909593CompletedNot Applicable

Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study

Boston Scientific Corporation2 sites in 1 country21 target enrollmentStarted: May 24, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
2
Primary Endpoint
Perception Threshold
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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.

Outcomes

Primary Outcomes

Perception Threshold

Time Frame: Programming Visit (up to 15 days post-screening)

Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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Study to Evaluate Automated Intensity... | Clinical Trial