Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial (AIM)

December 2, 2024 updated by: Boston Scientific Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • PCPMG Clinical Research Unit, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Spinal Cord Stimulation
Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
Other Names:
  • neurostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Programming Visit (up to 15 days post-screening)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Actual)

November 22, 2022

Study Completion (Actual)

November 22, 2022

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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