What is the mechanism of action of this treatment?

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion Stimulation (DRGS) are common treatments for chronic pain that work by modulating pain processing within the central nervous system. SCS delivers electrical impulses to the spinal cord to interfere with pain signal transmission to the brain, while DRGS targets specific nerve roots for similar effects. The dynamic adjustment of SCS parameters based on real-time physiological feedback aims to optimize pain relief by continuously adapting to the patient's current state. This personalized and responsive approach can lead to better pain management outcomes and improved quality of life for chronic pain patients.

What side effects are associated with this type of intervention?

Common treatments for chronic pain, such as Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) stimulation, are generally well-tolerated but can have side effects. These may include infection at the implant site, lead migration, hardware malfunction, and pain at the implant site. Some patients may also experience uncomfortable sensations or changes in stimulation over time. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of chronic pain. Spinal Cord Stimulation (SCS) systems, such as the 10 kHz SCS therapy (Senza® system), have shown efficacy in treating chronic back and leg pain. Additionally, Transcranial Magnetic Stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS) have been approved for specific pain conditions. These devices work by modulating neural activity to provide pain relief and are similar in concept to the Automated Physiologic Signal-Based Adjustment System being studied, which aims to dynamically adjust SCS parameters based on real-time physiological feedback.

What other types of research exist?

Promising novel alternatives for chronic pain treatment in 2024 include: 1) Non-invasive fetal ECG systems that can extract fetal heart signals from maternal noise, potentially adaptable for chronic pain monitoring. 2) Long-term monitoring methods using ballistocardiogram (BCG) and heart rate variability (HRV) to assess autonomic nervous system activity. 3) Automated real-time data acquisition systems for cardiorespiratory function, which require minimal operator intervention and have been tested for accuracy under extreme conditions. 4) Bayesian vectorcardiographic loop alignment methods for improved ECG monitoring and movement classification, which could enhance diagnostics and treatment adjustments.

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Device

Automated Spinal Cord Stimulation for Chronic Pain (AIM Trial)

N/A

Waitlist Available

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up programming visit (up to 15 days post-screening)

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical SCS-related side effects may include discomfort at the implant site, unwanted changes in stimulation felt by the patient, potential lead migration causing varied sensations or loss of therapy effect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ programming visit (up to 15 days post-screening)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~programming visit (up to 15 days post-screening)

This trial's timeline: 3 weeks for screening, Varies for treatment, and programming visit (up to 15 days post-screening) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perception Threshold

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT03284411

10%

Device stimulation issue

Inadequate analgesia

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Spinal Cord Stimulation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Spinal Cord StimulationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal Cord Stimulation

2020

Completed Phase 4

~440

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion Stimulation (DRGS) are common treatments for chronic pain that work by modulating pain processing within the central nervous system. SCS delivers electrical impulses to the spinal cord to interfere with pain signal transmission to the brain, while DRGS targets specific nerve roots for similar effects. The dynamic adjustment of SCS parameters based on real-time physiological feedback aims to optimize pain relief by continuously adapting to the patient's current state. This personalized and responsive approach can lead to better pain management outcomes and improved quality of life for chronic pain patients.

Machine learning approaches applied in spinal pain research.The moderating effects of pain catastrophizing on the relationship between illness perceptions and self-reported signs of central sensitization in patients with persistent pain.Quantitative Sensory Testing of Spinal Cord and Dorsal Root Ganglion Stimulation in Chronic Pain Patients.