Automated Spinal Cord Stimulation for Chronic Pain

(AIM Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if using body signals to automatically adjust spinal cord stimulation can help patients manage pain more effectively.

Research Team

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Neuromodulation Corporation

Eligibility Criteria

This trial is for adults who can clearly describe their pain and sensation, are undergoing a temporary Spinal Cord Stimulation (SCS) trial with an approved BSC neurostimulator system, and have signed informed consent. It's not for those with contraindications to BSC systems, suspected lead migration issues during the SCS trial, cognitive impairments that affect sensation reporting, or physical conditions preventing completion of study assessments.

Inclusion Criteria

I am currently trying out a specific approved neurostimulator system.

Subject signed a valid, EC/IRB-approved informed consent form.

The doctor believes you can clearly explain where and how you feel sensations and pain.

Exclusion Criteria

The doctor thinks the implanted lead for spinal cord stimulation might have moved a lot, which could make it hard for the person to get the right treatment.

You have a medical condition that makes it unsafe for you to use the BSC neurostimulation system.

I have a physical condition that may prevent me from completing study tasks.

Treatment Details

Interventions

• Spinal Cord Stimulation (Device)

Trial Overview The study aims to test if physiologic signals can be used to automatically adjust stimulation levels in patients receiving Spinal Cord Stimulation (SCS) therapy for various chronic pain conditions like neuropathic and lower back pain.

Participant Groups

Group I: Spinal Cord Stimulation Experimental Treatment 1 Intervention

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

Spinal Cord Stimulation is already approved in Canada for the following indications:

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology