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Title: 66361 TL1 Team Approach to Predicting Response to Spinal Cord Stimulation for Chronic Low Back Pain
ABSTRACT IMPACT: Understanding how spinal cord stimulation works and who it works best for will improve clinical trial efficacy and prevent unnecessary surgeries. OBJECTIVES/GOALS: Spinal cord stimulation (SCS) is an intervention for chronic low back pain where standard interventions fail to provide relief. However, estimates suggest only 58% of patients achieve at least 50% reduction in their pain. There is no non-invasive method for predicting relief provided by SCS. We hypothesize neural activity in the brain can fill this gap. METHODS/STUDY POPULATION: We tested SCS patients at 3 times points: baseline (pre-surgery), at day 7 during the trial period (post-trial), and 6 months after a permanent system had been implanted. At each time point participants completed 10 minutes of eyes closed, resting electroencephalography (EEG) and self-reported their pain. EEG was collected with the ActiveTwo system and a 128-electrode cap. Patients were grouped based on the percentage change of their pain from baseline to the final visit using a median split (super responders > average responders). Spectral density powerbands were extracted from resting EEG to use as input features for machine learning analyses. We used support vector machines to predict response to SCS. RESULTS/ANTICIPATED RESULTS: Baseline and post-trial EEG data predicted SCS response at 6-months with 95.56% and 100% accuracy, respectively. The gamma band had the highest performance in differentiating responders. Post-trial EEG data best differentiated the groups with feature weighted dipoles being more highly localized in sensorimotor cortex. DISCUSSION/SIGNIFICANCE OF FINDINGS: Understanding how SCS works and who it works best for is the long-term objective of our collaborative research program. These data provide an important first step towards this goal.  more » « less
Award ID(s):
1908299
NSF-PAR ID:
10296700
Author(s) / Creator(s):
; ; ;
Date Published:
Journal Name:
Journal of Clinical and Translational Science
Volume:
5
Issue:
s1
ISSN:
2059-8661
Page Range / eLocation ID:
111 to 112
Format(s):
Medium: X
Sponsoring Org:
National Science Foundation
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  1. Introduction: Back pain is one of the most common causes of pain in the United States. Spinal cord stimulation (SCS) is an intervention for patients with chronic back pain (CBP). However, SCS decreases pain in only 58% of patients and relies on self-reported pain scores as outcome measures. An SCS trial is temporarily implanted for seven days and helps to determine if a permanent SCS is needed. Patients that have a >50% reduction in pain from the trial stimulator makes them eligible for permanent implantation. However, self-reported measures reveal little on how mechanisms in the brain are altered. Other measurements of pain intensity, onset, medication, disabilities, depression, and anxiety have been used with machine learning to predict outcomes with accuracies <70%. We aim to predict long-term SCS responders at 6-months using baseline resting EEG and machine learning. Materials and Methods: We obtained 10-minutes of resting electroencephalography (EEG) and pain questionnaires from nine participants with CBP at two time points: 1) pre-trial baseline. 2) Six months after SCS permanent implant surgery. Subjects were designated as high or moderate responders based on the amount of pain relief provided by the long-term (post six months) SCS, and pain scored on a scale of 0-10 with 0 being no pain and 10 intolerable. We used the resting EEG from baseline to predict long-term treatment outcome. Resting EEG data was fed through a pipeline for classification and to map dipole sources. EEG signals were preprocessed using the EEGLAB toolbox. Independent component analysis and dipole fitting were used to linearly unmix the signal and to map dipole sources from the brain. Spectral analysis was performed to obtain the frequency distribution of the signal. Each power band, delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-100 Hz), as well as the entire spectrum (1-100 Hz), were used for classification. Furthermore, dipole sources were ranked based on classification feature weights to determine the significance of specific regions in the brain. We used support vector machines to predict pain outcomes. Results and Discussion: We found higher frequency powerbands provide overall classification performance of 88.89%. Differences in power are seen between moderate and high responders in both the frontal and parietal regions for theta, alpha, beta, and the entire spectrum (Fig.1). This can potentially be used to predict patient response to SCS. Conclusions: We found evidence of decreased power in theta, alpha, beta, and entire spectrum in the anterior regions of the parietal cortex and posterior regions of the frontal cortex between moderate and high responders, which can be used for predicting treatment outcomes in long-term pain relief from SCS. Long-term treatment outcome prediction using baseline EEG data has the potential to contribute to decision making in terms of permanent surgery, forgo trial periods, and improve clinical efficiency by beginning to understand the mechanism of action of SCS in the human brain. 
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  2. null (Ed.)
    OBJECTIVES/GOALS: Spinal cord stimulation (SCS) is an intervention for patients with chronic back pain. Technological advances have led to renewed optimism in the field, but mechanisms of action in the brain remain poorly understood. We hypothesize that SCS outcomes will be associated with changes in neural oscillations. METHODS/STUDY POPULATION: The goal of our team project is to test patients who receive SCS at 3 times points: baseline, at day 7 during the trial period, and day 180 after a permanent system has been implanted. At each time point participants will complete 10 minutes of eyes closed, resting electroencephalography (EEG). EEG will be collected with the ActiveTwo system, a 128-electrode cap, and a 256 channel AD box from BioSemi. Traditional machine learning methods such as support vector machine and more complex models including deep learning will be used to generate interpretable features within resting EEG signals. RESULTS/ANTICIPATED RESULTS: Through machine learning, we anticipate that SCS will have a significant effect on resting alpha and beta power in sensorimotor cortex. DISCUSSION/SIGNIFICANCE OF IMPACT: This collaborative project will further the application of machine learning in cognitive neuroscience and allow us to better understand how therapies for chronic pain alter resting brain activity. 
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  3. Background:

    Painful diabetic neuropathy (PDN) is a progressive condition that deprives many patients of quality of life. With limited treatment options available, successful pain management can be difficult to achieve.

    Methods:

    We reviewed results of recent data evaluating high frequency spinal cord stimulation (SCS).

    Results

    from the SENZA-PDN randomized clinical trial (NCT03228420), the largest such trial to date, demonstrated 10-kHz spinal cord stimulation substantially reduced PDN refractory to conventional medical management along with improvements in health-related quality-of-life measures that were sustained over 12 months. These data supported the recent U.S. Food & Drug Administration (FDA) approval for 10-kHz SCS in PDN patients and contributed to the body of evidence on SCS available to health care professionals managing the effects of PDN.

    Conclusion:

    High frequency spinal cord simulation appears to hold promise in treatment of painful diabetic neuropathy. We look forward to future works in the literature that will further elucidate these promising findings.

     
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