Tissue Temperature Increases by a 10 kHz Spinal Cord Stimulation System: Phantom and Bioheat Model

Zannou, Adantchede L.; Khadka, Niranjan; FallahRad, Mohamad; Truong, Dennis Q.; Kopell, Brian H.; Bikson, Marom

doi:10.1111/ner.12980

Cited by 29 publications

(27 citation statements)

References 44 publications

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“…10,11,29,33,34 Durable and differentiated outcomes seen with 10 kHz SCS treatment may be attributed to its unique mechanism of action. [35][36][37][38][39][40][41][42] Using in vivo and ex vivo electrophysiological approaches, Lee et al reported that unlike low-intensity (sub-sensory threshold) 1 kHz and 5 kHz SCS, 10 kHz SCS selectively activated inhibitory interneurons in the spinal dorsal horn (DH) and proposed that low-intensity 10 kHz SCS provided paresthesia-free pain relief possibly by activating the inhibitory interneurons without activating dorsal column fibers. 35 Researchers from Chang Gung Memorial Hospital, Taiwan used spared nerve injury…”

mentioning

confidence: 99%

<p>Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study</p>

Burgher

Kosek²,

Surrett³

et al. 2020

JPR

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Background Chronic upper extremity pain (UEP) has complex etiologies and is often disabling. It has been shown that 10 kHz SCS can provide paresthesia-free and durable pain relief in multiple pain types and improve the quality of life of patients. Objective To gain additional evidence on the safety and effectiveness of 10 kHz SCS for the treatment of chronic UEP. Study Design It was a prospective, multicenter, and observational study. The study was registered on ClinicalTrials.gov prospectively (clinical trial identifier: NCT02703818). Setting Multicenter. Patients, Intervention and Main Outcomes A total of 43 subjects with chronic UEP of ≥5 cm (on a 0–10 cm visual analog scale; VAS) underwent a trial of 10 kHz SCS, and subjects with ≥40% pain relief received a permanent implant. All subjects had upper limb pain at baseline, while some had concomitant shoulder or neck pain. Subject outcomes were assessed for 12 months, and the primary outcome was the responder rate (percentage of subjects experiencing ≥50% pain relief from baseline) at three months. Results Thirty-eight subjects successfully completed the trial (88.3% success rate), 33 received permanent implants (five withdrew consent), and 32 had device activation (per protocol population). There were no paresthesias or uncomfortable changes in stimulation related to changes in posture during the study and there were no neurological deficits. Responder rates at 12 months for upper limb, shoulder, and neck pain in per protocol population (N=32) were 78.1%, 85.2%, and 75.0%, respectively. At 12 months, 84.4% of subjects were satisfied or very satisfied with 10 kHz SCS, and 38.7% either reduced or eliminated opioid usage. Conclusion This study further supports the effectiveness of 10 kHz SCS for chronic UEP treatment and documents the safety profile of the therapy. Clinical Trial Identifier NCT02703818.

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confidence: 99%

<p>Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study</p>

Burgher

Kosek²,

Surrett³

et al. 2020

JPR

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“…The biophysics of heating are analogous experimentally verified prior simulations of conventional rate DBS and kHz SCS , however comparisons highlight the importance of stimulation dose (electrodes and waveform) as well as tissue anatomy and parameters. Compared to monopolar stimulation, energizing an adjacent contact in a bipolar electrode configuration may further increase temperature .…”

Section: Discussionmentioning

confidence: 63%

“…Static RMS values were applied (Eqn. (3)) for tested clinical kHz‐DBS intensities (3‐7 mA peak at 30 μs and 10 kHz), and this approach was supported by prior phantom verification for conventional DBS and kHz‐SCS .

I_{RMS} = I_{Peak} \sqrt{t * f} = I_{Peak} \sqrt{D}

where I RMS is the corresponding RMS value of peak stimulation intensity ( I peak ), t is the combined (anodic and cathodic phase) pulse width, f is the frequency, and D is the duty cycle.…”

Section: Methodsmentioning

confidence: 78%

Bio-Heat Model of Kilohertz-Frequency Deep Brain Stimulation Increases Brain Tissue Temperature

Khadka

Harmsen

Lozano

et al. 2020

Neuromodulation: Technology at the Neural Interface

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“…Impedance is also directly proportional to the energy consumption of the IPG, thus making it also proportional to the battery life of the device itself [8]. However, more recently this theory has been challenged to suggest there is an inverse relationship between impedance and the energy: E = (V2 9 pulse width 9 f)/R [9]. SCS systems are unable to transition to MRI-conditional modes in states of high impedance, as interactions generated by the MRI machine can [10].…”

Section: Discussionmentioning

confidence: 99%

“…Lead fracture was one of the drivers behind long-term failure rates of 5.9%, some diagnosed by routine impedance testing [9] North et al…”

Section: Lead Fracturementioning

confidence: 99%

Failure of SCS MR-Conditional Modes Due to High Impedance: A Review of Literature and Case Series

et al. 2020

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Introduction: Magnetic resonance imaging (MRI) conditional modes are a novel feature for certain Food and Drug Administration (FDA)approved spinal cord stimulation (SCS) devices. However, there is a paucity of literature around the limitation of MRI-conditional modes (''MRI safe''), specifically in clinical scenarios where urgent MRIs may be needed. One such limitation is load impedance, referring to the circuit's resistance to the current being generated by the system. High impedance can limit the MRIconditional mode capability, presenting potential harm to a patient undergoing an MRI or make an MRI unable to be completed. Methods: Three cases were identified, and informed consent was obtained. All information was obtained via retrospective chart review. Results: In this case series of three patients where MRI-conditional SCS systems were unable to be placed in ''MRI safe'' settings, preventing timely MRI study completion in the setting of high impedance, all three were required to undergo alternative imaging including CT scans, and two patients ultimately had the system explanted and one chose to be re-implanted after completion of scans. Conclusion: This case series highlights the need for further investigation of impedance in SCS systems and potential limitations for future MRI usage. The review of literature of impedance in SCS shows both device-and physiologic-related etiologies for changes in impedance that warrant consideration by the implanting physician.

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Tissue Temperature Increases by a 10 kHz Spinal Cord Stimulation System: Phantom and Bioheat Model

Cited by 29 publications

References 44 publications

<p>Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study</p>

<p>Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study</p>

Bio-Heat Model of Kilohertz-Frequency Deep Brain Stimulation Increases Brain Tissue Temperature

Failure of SCS MR-Conditional Modes Due to High Impedance: A Review of Literature and Case Series

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