Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain
Authors' conclusion
The results suggest that a physiological adherence to supra-ECAP threshold therapy that generates pain inhibition provided by ECAP-controlled CL-SCS leads to durable improvements in pain intensity with no evidence of loss of therapeutic effect through 36-month follow-up.
Study context
- Population
- Patients with chronic overall back and leg pain randomised to CL-SCS in the EVOKE trialfollowed up through 36 months
- Participants
- 41 patients
- Primary endpoint
- ECAP dose and accuracy sustaining durability of clinical improvements
- Follow-up
- 36 months
Methodological detailsdouble-blind, single-group cohort, 36-month follow-up
- Double-blind
- Single-group cohort
- 36-month follow-up
Primary result
As reported in the abstract
Neurophysiological measures of spinal cord activation
Elicited ECAP kept within target ECAP across all timepoints (µV)
4
Percent time stimulating above ECAP threshold
>98%
ECAP dose (µV)
≥19.3
Further findings
≥50% reduction in overall back and leg pain · 36 months
- Most patients obtained ≥50% reduction in overall back and leg pain
- 83%
- Sustained response in rates between 3-month and 36-month follow-up
- P = 0.083
≥80% reduction in overall back and leg pain · 36 months
- Most patients obtained ≥80% reduction in overall back and leg pain
- 59%
- Sustained response in rates between 3-month and 36-month follow-up
- P = 0.405
Original publication
Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain. Reg Anesth Pain Med. Published 15 March 2024. doi:10.
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