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

Primary Purpose

Chronic Pain, Intractable Pain, Low Back Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Spinal Cord Stimulation

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

PCPMG Clinical Research Unit, LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Stimulation

Arm Description

SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.

Outcomes

Primary Outcome Measures

Perception Threshold

Percent change in perception threshold from sitting to standing

Secondary Outcome Measures

Full Information

NCT ID

NCT04909593

First Posted

May 21, 2021

Last Updated

October 3, 2023

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04909593

Brief Title

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

Acronym

AIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 24, 2021 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Intractable Pain, Low Back Pain, Pain, Neuropathic, Pain, Back

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spinal Cord Stimulation

Arm Type

Experimental

Arm Description

SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.

Intervention Type

Device

Intervention Name(s)

Spinal Cord Stimulation

Other Intervention Name(s)

neurostimulation

Intervention Description

Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters

Primary Outcome Measure Information:

Title

Perception Threshold

Description

Percent change in perception threshold from sitting to standing

Time Frame

up to 15 days post-screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gerard Herro

Phone

855-213-9890

BSNClinicalTrials@bsci.com

First Name & Middle Initial & Last Name or Official Title & Degree

Keesey Diane

Phone

855-213-9890

BSNClinicalTrials@bsci.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Bloom Lyons

Organizational Affiliation

Boston Scientific Neuromodulation Corporation

Official's Role

Study Director

Facility Information:

Facility Name

PCPMG Clinical Research Unit, LLC

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Boston Scientific Clinical Research Manager

Phone

855-213-9890

BSNClinicalTrials@bsci.com

First Name & Middle Initial & Last Name & Degree

Eric P Loudermilk, MD

12. IPD Sharing Statement

Learn more about this trial

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

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