Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial DOI Creative Commons
Leonardo Kapural, Nagy Mekhail, Shrif Costandi

et al.

Regional Anesthesia & Pain Medicine, Journal Year: 2023, Volume and Issue: 49(4), P. 233 - 240

Published: July 25, 2023

Introduction Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials chronic interventions, however, remains primarily focused on treatment effects intensity. This study investigates a novel, multidimensional holistic response to evoked compound action potential-controlled closed-loop versus open-loop spinal cord stimulation as well the degree neural activation that produced response. Methods Outcome data for intensity, physical function, quality life, sleep emotional function were derived from individual patient level EVOKE multicenter, participant, investigator, outcome assessor-blinded, parallel-arm randomized controlled trial with 24 month follow-up. Evaluation considered whether baseline score was worse than normative values minimal important differences reached each domains impaired at baseline. A cumulative responder calculated reflect total accumulated across all Objective neurophysiological data, including measured. Results Patients (n=67) or (n=67). greater proportion (49.3% vs 26.9%) responders 24-month follow-up, least one difference (absolute risk difference: 22.4%, 95% CI 6.4% 38.4%, p=0.012). significantly time points resulted achievement more three additional follow-up (mean 3.4, 1.3 5.5, p=0.002). Neural times accurate (p<0.001 points). Conclusion results this suggest can provide sustained clinically meaningful improvements improvement long-term refractory pain. Trial registration number NCT02924129 .

Language: Английский

Predicting the Response of High Frequency Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: A Retrospective Study with Machine Learning Techniques DOI Open Access
Lisa Goudman,

Jean‐Pierre Van Buyten,

Ann De Smedt

et al.

Journal of Clinical Medicine, Journal Year: 2020, Volume and Issue: 9(12), P. 4131 - 4131

Published: Dec. 21, 2020

Despite the proven clinical value of spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS), factors related to a successful SCS outcome are not yet clearly understood. This study aimed predict responders high frequency at 10 kHz (HF-10). Data before implantation and last available data was extracted 119 FBSS treated HF-10 SCS. Correlations, logistic regression, linear discriminant analysis, classification regression trees, random forest, bagging, boosting were applied. Based on feature selection, trial pain relief, predominant location, number previous surgeries relevant predicting relief. To 50% 58.33% accuracy obtained boosting, forest bagging. For 30% 70.83% using trees. medication decrease, accuracies above 80% analysis. Several machine learning techniques able an acceptable accuracy. However, none revealed The inconsistent results regarding predictive in literature, combined currently models, might suggest that routinely collected baseline parameters from practice sufficient consistently response long-term.

Language: Английский

Citations

20
Ultra-Low Energy Cycled Burst Spinal Cord Stimulation Yields Robust Outcomes in Pain, Function, and Affective Domains: A Subanalysis From Two Prospective, Multicenter, International Clinical Trials DOI
Timothy R. Deer,

Derron Wilson,

David M. Schultz

et al.

Neuromodulation Technology at the Neural Interface, Journal Year: 2021, Volume and Issue: 25(1), P. 137 - 144

Published: July 27, 2021

Language: Английский

Citations

16
Burst spinal cord stimulation can attenuate pain and its affective components in chronic pain patients with high psychological distress: results from the prospective, international TRIUMPH study DOI
Jonathan M. Hagedorn, Steven Falowski, Bram Blomme

et al.

The Spine Journal, Journal Year: 2021, Volume and Issue: 22(3), P. 379 - 388

Published: Aug. 20, 2021

Language: Английский

Citations

16
Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials DOI
Jonathan M. Hagedorn, Timothy R. Deer, Nicholas C. Canzanello

et al.

Regional Anesthesia & Pain Medicine, Journal Year: 2021, Volume and Issue: 46(4), P. 293 - 297

Published: Jan. 21, 2021

Spinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing spinal stimulator device recommended to assess patient's response neurostimulation before permanent implantation. The trial often assessed by Numeric Rating Scale changes and patient-reported percentage improvement. Using number rating scale between prespinal postspinal trial, a calculated improvement can be obtained. aim this study was difference in during trials.This retrospective single center review all trials from January 1 2017 July 2019. A total 174 patients were included. paired t-test compare numeric scores obtained prestimulation versus poststimulation. mean methods (patient-reported minus calculated) compared with zero using 1-sample t-test. Lin's concordance correlation coefficient computed 95% CI, Fisher z-transformation; bootstrapping approach groups. In cases, two-tailed tests p<0.05 considered statistically significant.Based on poststimulation scores, mean±SD 54±28. 59±25. overall limits agreement two are -30% +41%. 0.76 (95% CI 0.69 0.81).Although highly correlated, there substantial lack scale, suggesting that these measures should not interchangeably outcome assessment. This emphasizes need improved metrics better measure patient neuromodulation therapies. Additionally, found higher than pain, potentially highlighting multidimensional experience unpredictability solely outcomes.

Language: Английский

Citations

15
Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial DOI Creative Commons
Leonardo Kapural, Nagy Mekhail, Shrif Costandi

et al.

Regional Anesthesia & Pain Medicine, Journal Year: 2023, Volume and Issue: 49(4), P. 233 - 240

Published: July 25, 2023

Introduction Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials chronic interventions, however, remains primarily focused on treatment effects intensity. This study investigates a novel, multidimensional holistic response to evoked compound action potential-controlled closed-loop versus open-loop spinal cord stimulation as well the degree neural activation that produced response. Methods Outcome data for intensity, physical function, quality life, sleep emotional function were derived from individual patient level EVOKE multicenter, participant, investigator, outcome assessor-blinded, parallel-arm randomized controlled trial with 24 month follow-up. Evaluation considered whether baseline score was worse than normative values minimal important differences reached each domains impaired at baseline. A cumulative responder calculated reflect total accumulated across all Objective neurophysiological data, including measured. Results Patients (n=67) or (n=67). greater proportion (49.3% vs 26.9%) responders 24-month follow-up, least one difference (absolute risk difference: 22.4%, 95% CI 6.4% 38.4%, p=0.012). significantly time points resulted achievement more three additional follow-up (mean 3.4, 1.3 5.5, p=0.002). Neural times accurate (p<0.001 points). Conclusion results this suggest can provide sustained clinically meaningful improvements improvement long-term refractory pain. Trial registration number NCT02924129 .

Language: Английский

Citations

6