In-Clinic and At-Home Patient Experiences with Closed-Loop Spinal Cord Stimulation: 12-Month Outcomes from the...

Area of Science:

• Neuromodulation
• Pain Management
• Spinal Cord Stimulation

Background:

• Closed-loop spinal cord stimulation (CL-SCS) utilizes evoked compound action potential (ECAP) feedback for dynamic amplitude adjustment.
• This technology aims to mitigate under- and overstimulation during patient movement and postural changes.
• The Closed-Loop Australia study investigated 12-month patient-reported outcomes of CL-SCS.

Purpose of the Study:

• To compare overstimulation rates between CL-SCS and open-loop (OL) SCS during specific movements.
• To assess patient-reported stimulation characteristics and pain intensity at 12 months.
• To evaluate the efficacy of adaptable stimulation strategies in chronic pain management.

Main Methods:

• A multicenter, prospective, single-arm study design.
• Randomized in-clinic crossover testing to evaluate primary outcome (overstimulation).
• Secondary outcomes included patient-reported comfort, activity engagement, and pain intensity via at-home therapy assessment.

Main Results:

• CL-SCS demonstrated significantly lower overstimulation rates (median 0.4) compared to OL-SCS (median 3) at 12 months.
• 85% of participants reported comfortable physical activity with CL-SCS, with 78% achieving ≥50% pain relief.
• Pain intensity decreased by 60 mm from baseline and remained stable throughout the study period.

Conclusions:

• Adaptable stimulation strategies, such as CL-SCS, are crucial for enhancing patient comfort.
• CL-SCS supports sustained pain relief and improves the ability to perform daily activities.
• These findings highlight the potential of closed-loop systems in optimizing spinal cord stimulation therapy.