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

Boston Scientific

Status

Completed

Conditions

Pain, Back

Intractable Pain

Chronic Pain

Pain, Neuropathic

Low Back Pain

Treatments

Device: Spinal Cord Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04909593

A4091

Details and patient eligibility

About

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).

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.