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Temperature increases by kilohertz frequency spinal cord stimulation.

ABSTRACT: INTRODUCTION:Kilohertz frequency spinal cord stimulation (kHz-SCS) deposits significantly more power in tissue compared to SCS at conventional frequencies, reflecting increased duty cycle (pulse compression). We hypothesize kHz-SCS increases local tissue temperature by joule heat, which may influence the clinical outcomes. METHODS:To establish the role of tissue heating in KHZ-SCS, a decisive first step is to characterize the range of temperature changes expected during conventional and KHZ-SCS protocols. Fiber optic probes quantified temperature increases around an experimental SCS lead in a bath phantom. These data were used to verify a SCS lead heat-transfer model based on joule heat. Temperature increases were then predicted in a seven-compartment (soft tissue, vertebral bone, fat, intervertebral disc, meninges, spinal cord with nerve roots) geometric human spinal cord model under varied parameterization. RESULTS:The experimentally constrained bio-heat model shows SCS waveform power (waveform RMS) determines tissue heating at the spinal cord and surrounding tissues. For example, we predict temperature increased at dorsal spinal cord of 0.18-1.72?°C during 3.5?mA peak 10?KHz stimulation with a 40-10-40 ?s biphasic pulse pattern, 0.09-0.22?°C during 3.5?mA 1?KHz 100-100-100 ?s stimulation, and less than 0.05?°C during 3.5?mA 50?Hz 200-100-200 ?s stimulation. Notably, peak heating of the spinal cord and other tissues increases superlinearly with stimulation power and so are especially sensitive to incremental changes in SCS pulse amplitude or frequency (with associated pulse compression). Further supporting distinct SCS intervention strategies based on heating; the spatial profile of temperature changes is more uniform compared to electric fields, which suggests less sensitivity to lead position. CONCLUSIONS:Tissue heating may impact short and long-term outcomes of KHZ-SCS, and even as an adjunct mechanism, suggests distinct strategies for lead position and programming optimization.

SUBMITTER: Zannou AL

PROVIDER: S-EPMC6301103 | biostudies-literature | 2019 Jan - Feb

REPOSITORIES: biostudies-literature

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Temperature increases by kilohertz frequency spinal cord stimulation.

Zannou Adantchede L AL Khadka Niranjan N Truong Dennis Q DQ Zhang Tianhe T Esteller Rosana R Hershey Brad B Bikson Marom M

Brain stimulation 20181017 1

<h4>Introduction</h4>Kilohertz frequency spinal cord stimulation (kHz-SCS) deposits significantly more power in tissue compared to SCS at conventional frequencies, reflecting increased duty cycle (pulse compression). We hypothesize kHz-SCS increases local tissue temperature by joule heat, which may influence the clinical outcomes.<h4>Methods</h4>To establish the role of tissue heating in KHZ-SCS, a decisive first step is to characterize the range of temperature changes expected during convention ...[more]

PMID: 30482674

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Project description:Background and objectivesMultiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach.Materials and methodsVectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction.ResultsThere was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit.ConclusionsLong-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow.Clinical trial registrationThe Clinicaltrials.gov registration number for the study is NCT03345472.

Project description:Deep brain stimulation (DBS) is an established therapy for movement disorders, including tremor, dystonia, and Parkinson's disease, but the mechanisms of action are not well understood. Symptom suppression by DBS typically requires stimulation frequencies ?100 Hz, but when the frequency is increased above ~2 kHz, the effectiveness in tremor suppression declines (Benabid et al., 1991). We sought to test the hypothesis that the decline in efficacy at high frequencies is associated with desynchronization of the activity generated within a population of stimulated neurons. Regularization of neuronal firing is strongly correlated with tremor suppression by DBS, and desynchronization would disrupt the regularization of neuronal activity. We implemented computational models of CNS axons with either deterministic or stochastic membrane dynamics, and quantified the response of populations of model nerve fibers to extracellular stimulation at different frequencies and amplitudes. As stimulation frequency was increased from 2 to 80 Hz the regularity of neuronal firing increased (as assessed with direct estimates of entropy), in accord with the clinical effects on tremor of increasing stimulation frequency (Kuncel et al., 2006). Further, at frequencies between 80 and 500 Hz, increasing the stimulation amplitude (i.e., the proportion of neurons activated by the stimulus) increased the regularity of neuronal activity across the population, in accord with the clinical effects on tremor of stimulation amplitude (Kuncel et al., 2007). However, at stimulation frequencies above 1 kHz the regularity of neuronal firing declined due to irregular patterns of action potential generation and conduction block. The reductions in neuronal regularity that occurred at high frequencies paralleled the previously reported decline in tremor reduction and may be responsible for the loss of efficacy of DBS at very high frequencies. This analysis provides further support for the hypothesis that effective DBS masks the intrinsic patterns of activity in the stimulated neurons and replaces it with regularized firing.

Project description:Background: Chronic spinal cord injury (SCI) portends a low probability of recovery, especially in the most severe subset of motor-complete injuries. Active spinal cord stimulation with or without intensive locomotor training has been reported to restore movement after traumatic SCI. Only three cases have been reported where participants developed restored volitional movement with active stimulation turned off after a period of chronic stimulation and only after intensive rehabilitation with locomotor training. It is unknown whether restoration of movement without stimulation is possible after stimulation alone. Objective: We describe the development of spontaneous volitional movement (SVM) without active stimulation in a subset of participants in the Epidural Stimulation After Neurologic Damage (ESTAND) trial, in which locomotor training is not prescribed as part of the study protocol, and subject's rehabilitation therapies are not modified. Methods: Volitional movement was evaluated with the Brain Motor Control Assessment using sEMG recordings and visual examination at baseline and at follow-up visits with and without stimulation. Additional functional assessment with a motor-assisted bicycle exercise at follow-up with and without stimulation identified generated work with and without effort. Results: The first seven participants had ASIA Impairment Scale (AIS) A or B thoracic SCI, a mean age of 42 years, and 7.7 years post-injury on average. Four patients developed evidence of sustained volitional movement, even in the absence of active stimulation after undergoing chronic epidural spinal cord stimulation (eSCS). Significant increases in volitional power were found between those observed to spontaneously move without stimulation and those unable (p < 0.0005). The likelihood of recovery of spontaneous volitional control was correlated with spasticity scores prior to the start of eSCS therapy (p = 0.048). Volitional power progressively improved over time (p = 0.016). Additionally, cycling was possible without stimulation (p < 0.005). Conclusion: While some SVM after eSCS has been reported in the literature, this study demonstrates sustained restoration without active stimulation after long-term eSCS stimulation in chronic and complete SCI in a subset of participants. This finding supports previous studies suggesting that "complete" SCI is likely not as common as previously believed, if it exists at all in the absence of transection and that preserved pathways are substrates for eSCS-mediated recovery in clinically motor-complete SCI. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03026816.

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Temperature increases by kilohertz frequency spinal cord stimulation.

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Temperature increases by kilohertz frequency spinal cord stimulation.

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