Updates in Neuromodulation 2020 Kenneth B. Chapman, MD Director, Pain Medicine Staten Island University Hospital Assistant Clinical Professor, NYU Langone Medical Center Adjunct Assistant Professor, Zucker School of Medicine at Hofstra/Northwell
Disclosures: None
The Evolution of Neurostimulation for Pain 1967-1999 1999-2007 2007-2013 2013-2015 Psychological Improvements of Burst Expanded Indications with HF-10 Focus moves to Therapies other than DH Return to Paresthesia Based Waveform 1 Company 3 Companies Improvements in: Paresthesia 4 Contact lead Battery free 8 contact lead Leads stimulation Programming introduced
The Move to Paresthesia Fr Free Sti timulati tion ~Differ erences i s in n Paresthesi sia Fr Free B ee Bur urst~
Details of Passive Recharge Burst Stimulation Pulse Train Studied Passive Burst Stimulation Pulse Interburst Intraburst Parameters Width Frequency Frequency Interburst Burst Rate 40 Hz 1000 µS 40Hz 500 Hz Duration 25 ms Intra-Burst Rate 500 Hz Pulse Amplitude Pulse Width 1 us IPG systems do not allow passive (<60% Burst Train 5 pulses threshold) recharge Burst Train Duration 9 us Quiescence Period 16 us Active charge balance by flipping anode and cathode Patient Specific Parameters Interburst Burst Rate Variable Charge Balance Burst Train Interval Duration Variable 9 µS 16 µS Intra-Burst Rate Variable Pulse Width Variable Burst Train 4-9 pulses Dirk De Ridder et al. All bursts are equal, but some are more equal (to burst firing):burstDR stimulation versus Boston burst stimulation. Expert Review of Medical Devices DOI: 10.1080/17434440.2020.1736560
Intra and Extracellular Cellular Differences with Burst Firing Burst definition A burst is a train of action potentials that occurs during a ‘ plateau ’ or ‘active phase’, followed by a period of relative quiescence called the ‘silent phase’ Burst firing Clustered tonic firing Crunelli 2018 Weiergraeber 2010 Weiergräber M, Stephani U, Köhling R. Voltage-gated calcium channels in the etiopathogenesis and treatment of absence epilepsy. Brain Res Rev. 2010 Mar;62(2):245-71. Crunelli V, Lőrincz ML, Connelly WM, David F, Hughes SW, Lambert RC, Leresche N, Errington AC. Dual function of thalamic low-vigilance state oscillations: rhythm-regulation and plasticity. Nat Rev Neurosci. 2018 Feb;19(2):107-118.
Calcium Induced Bursting leads to non-linear responses Non-linear post- Linear 1:1 synaptic response response EPSP Active Recharge Burst Response Linear 1:1 response Synaptic Input Bursts Tonic Passive Recharge Burst Non-linear post-synaptic response Sherman SM. Tonic and burst firing: dual modes of thalamocortical relay. Trends Neurosci. 2001 Feb;24(2):122-6 Falowski S. An Observational Case Series of Spinal Cord Stimulation Waveforms Visualized on Intraoperative Neuromonitoring. Neuromodulation. 2019. 22: 219-228
Burst type differences in Rodent Models Average MTs were significant different for active recharge Passive Recharge Burst: burst (37 ± 21 μ A) compared to passive recharge burst (200 ± 61 μ A). LOWER AMPLITUDES ARE BETTER 1.5 mA (±0.9) 0.6 mA (±0.4) 62% 91% paresthesia free Active Recharge Burst: HIGHER AMPLITUDES ARE BETTER Sunburst optimization Kent et al. Burst & High-Frequency Spinal Cord Stimulation Differentially Effect Spinal Neuronal Activity After Radiculopathy. Ann Biomed Eng. 2020 Jan;48(1):112-120. Epub 2019 Aug 5. PMID: 31385104. Meuwissen et al. Conventional-SCS vs. Burst-SCS and the Behavioral Effect on Mechanical Hypersensitivity in a Rat Model of Chronic Neuropathic Pain: Effect of Amplitude. Neuromodulation. 2018 Jan;21(1):19-30. doi: 10.1111/ner.12731. Epub 2017 Nov 27. PMID: 29178358. Leong et al. Potential Therapeutic Effect of Low Amplitude Burst Spinal Cord Stimulation on Pain. Neuromodulation. 2019 Dec 18. doi: 10.1111/ner.13090. Epub ahead of print. PMID: 31854070. Quindlen-Hotek JC, Kent AR, De Anda P, Kartha S, Benison AM, Winkelstein BA. Changes in Neuronal Activity in the Anterior Cingulate Cortex and Primary Somatosensory Cortex With Nonlinear Burst and Tonic Spinal Cord Stimulation. Neuromodulation. 2020 Jul;23(5):594-604. doi: 10.1111/ner
Interm ittent Dosing with Passive Burst Patient Population and design - Prospective, open label, multicenter, feasibility trial Results - Chronic intractable back and/or leg pain patients, no prior history of SCS - N=50 patients - 1, 3 and 6 month follow-up - 5 dosing protocols: • 30 on / 360 off • 30 on / 240 off • 30 on / 150 off 30 on / 120 off • 30 on / 90 off • 45.8% of patients utilized program with lowest dose setting 100% of patients received clinically relevant pain relief with dosed settings Patients are used therapy for six hours or less per day Deer et al. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation: Technology at the Neural Interface, 2020. DOI: 10.1111/ner.13143
Summary: Not all bursts are equal Passive recharge Burst ≠ Active recharge = Tonic stimulation Passive Burst Stimulation Active Burst Stimulation Descending pain inhibitory Descending pain inhibitory (pgACC, PHC) (pgACC, PHC) Lateral pain pathway (SSC) Lateral pain pathway (SSC) Non-linear stronger activator Medial pain pathway (rACC/DLPFC) Medial pain pathway (rACC/DLPFC) Rerouting/multiplexing Normalizes pain promoting/pain Decreases pain promoting/pain suppressing balance suppressing balance Dopamine? GABA Not via dorsal columns Dorsal columns Does it matter though?
Blood Oxygen Level-Dependent (BOLD)Functional MRI Acute noxious sensory stimulation caused robust BOLD fMRI response in brain regions previously associated with sensory and pain-related response, such as the primary/secondary somatosensory cortex, retrosplenial granular cortex, thalamus, caudate putamen, nucleus accumbens, globus pallidus, and amygdala. Lateral Pathway Medial Pathway Activation map Lateral pathway activation Medial pathway activation (objective aspects) with (emotional aspects) with Active Active Recharge Burst Recharge Burst De Ridder et al.Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12. Meuwissen K et al. Active Recharge Burst and Tonic Spinal Cord Stimulation Engage Different Supraspinal Mechanisms: A Functional Magnetic Resonance Imaging Study in Peripherally Injured Chronic Neuropathic Rats. Pain Pract. 2020 Jun;20(5):510-521. Pawela CP, Kramer JM, Hogan QH. Dorsal root ganglion stimulation attenuates the BOLD signal response to noxious sensory input in specific brain regions: Insights into a possible mechanism for analgesia. Neuroimage. 2017 Feb 15;147:10-18.
Patient Preference in Active Recharge Burst Stimulation 1 2 100% Patient preference (proportion of patients) Preference (%) 80% based on free use of different programs. 60% (N= 250) 40% 20% Proportion 0% of patients Tonic Burst no pref Tonic Burst no pref 3 100% Preference (%) 80% 60% Proportion 40% of waveforms 20% 0% Tonic Burst no pref Tonic Burst no pref 1. Berg AP, Mekel-Bobrov N, Goldberg E, Huynh D, Jain R. Utilization of multiple spinal cord stimulation (SCS) waveforms in chronic pain patients. Expert Rev Med Devices. 2017 Aug;14(8):663-668. 2. Deer et al. Success Using Neuromodulation With BURST 2.(SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. 3. Schu et al. A prospective, randomized, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014;17:443–450.
Multifidus Stimulation for Low Back Pain Multifidus
Muscle Control Impairment and Low Back Pain • Pain from muscle strain and injury can lead to muscle control disruption and weakening. • Atrophied multifidus is seen in 80% of CLBP patients. • Unstable joints can move outside their ‘pain-free range’ resulting in more pain and reinjury leading to a continued cycle of chronic pain. Severe multifidus atrophy (more than Mild multifidus muscle atrophy, (less than Moderate multifidus muscle atrophy (>10% 50% of CSA of muscle replaced with fat) 10% of CSA of muscle replaced with fat). but <50% of CSA of muscle replaced with fat). Freeman et al. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6 Panjabi M. Clinical spinal instability and low back pain. J Electromyogr Kinesiol. 2003 Aug;13(4):371-9. Kader et al. Correlation between the MRI changes in the lumbar multifidus muscles and leg pain Clin Radiol, 55 (2000), pp. 145-149
ReActiv8 Device Multifidus
ReActv8-A Baseline Characteristics • Younger patients • Pain >10 years • Mod/severe pain • Low end severe disability • 72% on opioids Deckers et al.New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial. Neuromodulation. 2018 Jan;21(1):48-55.
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