Pulse duration settings in subthalamic stimulation for Parkinson's disease.

BACKGROUND: Stimulation parameters in deep brain stimulation (DBS) of the subthalamic nucleus for Parkinson's disease (PD) are rarely tested in double-blind conditions. Evidence-based recommendations on optimal stimulator settings are needed. Results from the CUSTOM-DBS study are reported, comparing 2 pulse durations. METHODS: A total of 15 patients were programmed using a pulse width of 30 µs (test) or 60 µs (control). Efficacy and side-effect thresholds and unified PD rating scale (UPDRS) III were measured in meds-off (primary outcome). The therapeutic window was the difference between patients' efficacy and side effect thresholds. RESULTS: The therapeutic window was significantly larger at 30 µs than 60 µs (P = ·0009) and the efficacy (UPDRS III score) was noninferior (P = .00008). INTERPRETATION: Subthalamic neurostimulation at 30 µs versus 60 µs pulse width is equally effective on PD motor signs, is more energy efficient, and has less likelihood of stimulation-related side effects. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Ambulatory respiratory rate trends identify patients at higher risk of worsening heart failure in implantable cardioverter defibrillator and biventricular device recipients: a novel ambulatory parameter to optimize heart failure management.

PURPOSE: Respiratory distress is the primary driver for heart failure (HF) hospitalization. Implantable pacemakers and defibrillators are capable of monitoring respiratory rate (RR) in ambulatory HF patients. We investigated changes in RR prior to HF hospitalizations and its near-term risk stratification power. METHODS: NOTICE-HF was an international multi-center study. Patients were implanted with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, capable of trending daily maximum, median, and minimum RR (maxRR, medRR, minRR). RR from 120 patients with 9 months of follow-up was analyzed. One-tailed Student's t test was used to compare RR values prior to HF events to baseline defined as 4 weeks prior to the events. A Cox regression model was used to calculate the hazard ratios (HR) for the 30-day HF hospitalization risk based on RR values in the preceding month. RESULTS: Daily maxRR, medRR, and minRR were significantly elevated prior to HF events compared to baseline (ΔmaxRR 1.8 ± 3.0; p = 0.02; ΔmedRR, 2.1 ± 2.8; p = 0.007; ΔminRR, 1.5 ± 2.1, p = 0.008). Risk of experiencing HF events within 30-days was increased if the standard deviation of medRR over the preceding month was above 1.0 br/min (HR = 12.3, 95 % confidence interval (CI) 2.57-59, p = 0.002). The risk remained high after adjusting for clinical variables that differed at enrollment. CONCLUSION: Ambulatory daily respiratory rate trends may be a valuable addition to standard management for HF patients.

The effect of pulse width and contact configuration on paresthesia coverage in spinal cord stimulation.

BACKGROUND: In spinal cord stimulation for the management of chronic, intractable pain, a satisfactory analgesic effect can be obtained only when the stimulation-induced paresthesias cover all painful body areas completely or partially. OBJECTIVE: To investigate the effect of stimulus pulse width (PW) and contact configuration (CC) on the area of paresthesia (PA), perception threshold (VPT), discomfort threshold (VDT), and usage range (UR) in spinal cord stimulation. METHODS: Chronic pain patients were tested during a follow-up visit. They were stimulated monopolarly and with the CC giving each patient the best analgesia. VPT, VDT, and UR were determined for PWs of 90, 210, and 450 microseconds. The paresthesia contours at VDT were drawn on a body map and digitized; PA was calculated; and its anatomic composition was described. The effects of PW and CC on PA, VPT, VDT, and UR were tested statistically. RESULTS: Twenty-four of 31 tests with low thoracic stimulation and 8 of 9 tests with cervical stimulation gave a significant extension of PA at increasing PW. In 14 of 18 tests (low thoracic), a caudal extension was obtained (primarily in L5-S2). In cervical stimulation the extension was predominantly caudal as well. In contrast to VPT and VDT, UR is not significantly different when stimulating with any CC. CONCLUSION: PA extends caudally with increasing PW. The mechanism includes that the larger and smaller dorsal column fibers have a different mediolateral distribution and that smaller dorsal column fibers have a smaller UR and can be activated only when PW is sufficiently large. A similar effect of CC on PA is unlikely as long as electrodes with a large intercontact distance are applied.

Application of correlation techniques in the analysis of corpus cavernosum electromyographic signals.

AIM: To establish an objective, easy-to-use and comprehensive method to analyze corpus cavernosum electromyographic signals (CC-potentials). METHODS: CC-potentials were recorded during flaccidity in 23 young healthy volunteers, with surface electrodes placed on the penile shaft bilaterally. Based on the correlation function of Matlab software, an application program for the analysis of CC-potentials was developed. Individual CC-potentials and their autocorrelation function were evaluated, yielding parameters amplitude (A), duration (D), and dominant frequency (DF). The cross-correlation function of both longitudinal and bilateral pairs of adjacent electrodes was calculated to assess the similarity and mutual delay of CC-potentials recorded simultaneously from different parts of the CC. The parameters derived were squared maximum cross-correlation coefficient (Rmax) and delay (tau). Based on the absolute value of tau and the corresponding inter-electrode distance, propagation velocity (PV) was calculated. RESULTS: The values of the parameters were determined automatically. No significant difference related to the locations of the electrodes for parameters A, D, and DF was detected. The cross-correlation showed that both longitudinal and bilateral CC-potential pairs had highly similar waveforms (the absolute values of Rmax were 0.80 +/- 0.05 and 0.87 +/- 0.06, respectively). PV of longitudinal pairs was estimated as 6.15 +/- 3.98 cm/s. CONCLUSION: The application program for correlation analysis of CC-potentials is a comprehensive and versatile method to analyze corpus cavernosum electromyographic recordings. Its objectiveness makes multi-center application possible.

Anodal vs cathodal stimulation of motor cortex: a modeling study.

OBJECTIVE: To explore the effects of electrical stimulation performed by an anode, a cathode or a bipole positioned over the motor cortex for chronic pain management. METHODS: A realistic 3D volume conductor model of the human precentral gyrus (motor cortex) was used to calculate the stimulus-induced electrical field. The subsequent response of neural elements in the precentral gyrus and in the anterior wall and lip of the central sulcus was simulated using compartmental neuron models including the axon, soma and dendritic trunk. RESULTS: While neural elements perpendicular to the electrode surface are preferentially excited by anodal stimulation, cathodal stimulation excites those with a direction component parallel to its surface. When stimulating bipolarly, the excitation of neural elements parallel to the bipole axis is additionally facilitated. The polarity of the contact over the precentral gyrus determines the predominant response. Inclusion of the soma-dendritic model generally reduces the excitation threshold as compared to simple axon model. CONCLUSIONS: Electrode polarity and electrode position over the precentral gyrus and central sulcus have a large and distinct influence on the response of cortical neural elements to stimuli. SIGNIFICANCE: Modeling studies like this can help to identify the effects of electrical stimulation on cortical neural tissue, elucidate mechanisms of action and ultimately to optimize the therapy.

Theoretical investigation into longitudinal cathodal field steering in spinal cord stimulation.

Objective. When using spinal cord stimulation (SCS) for chronic pain management, precise longitudinal positioning of the cathode is crucial to generate an electrical field capable of targeting the neural elements involved in pain relief. Presently used methods have a poor spatial resolution and lack postoperative flexibility needed for fine tuning and reprogramming the stimulation field after lead displacement or changes in pain pattern. We describe in this article a new method, "electrical field steering," to control paresthesia in SCS. The method takes advantage of newer stimulator design and a programming technique allowing for "continuous" adjustment of contact combination while controlling stimulation current for each contact separately. Method. Using computer modeling we examined how stimulation of dorsal column (DC) and dorsal root (DR) fibers was influenced by changing the current ratio of the cathodes of a dual (--) and a guarded dual cathode (+--+) configuration programmed on a percutaneous lead with 9 and 4 mm center-to-center contact spacing. Results. A cathodal current ratio could be found for which DC or DR fiber recruitment and thus, most likely, paresthesia coverage was maximized. The DR threshold profiles shifted longitudinally, thus following the shift in the electrical field during steering. The profiles had a constant shape when the contact spacing was small and a varying shape for wider contact separation. Generally, the wider contact separation provided less DC and more DR fiber recruitment. Conclusions. By means of cathodal steering on a longitudinal contact array, the group of excited DC and DR fibers, and thus paresthesia coverage, can be controlled when using SCS. With widely spaced contacts, superposition of the electrical field from each steering contact is limited. To precisely control segmental paresthesia (DR stimulation), a small contact spacing is necessary.

Factors affecting impedance of percutaneous leads in spinal cord stimulation.

Objectives. Although the load impedance of a pulse generator has a significant effect on battery life, the electrical impedance of contact arrays in spinal cord stimulation (SCS) has not been extensively studied. We sought to characterize the typical impedance values measured from common quadripolar percutaneous SCS contact arrays. Methods. In 36 patients undergoing percutaneous trial stimulation for various chronic pain conditions, bipolar impedance between adjacent contacts of 64 leads with 9 mm center-to-center spacing was measured in two different vertebral level regions, cervical (C3-C7) and lower-thoracic (T7-T12). Multiple linear regression was applied to analyze the contribution of six variables to the biological tissue portion of the impedance (excluding the resistance of the lead wires). Results. The median impedance in the cervical region (351 ± 90 Ω) was significantly lower (36%, p < 0.001) than in the lower-thoracic region (547 ± 151 Ω). In addition, time since implant had a weaker but still significant effect on tissue impedance. Conclusions. Results from finite-difference mathematical modeling of SCS suggest that the difference in tissue impedance related to vertebral level may be due to the dorsoventral position of the lead in the epidural space. The presence of a larger space between the triangularly shaped dorsal part of the vertebral arch and the round shape of the dural sac in the lower-thoracic region increases the likelihood that the stimulating lead will not make dural contact, and thus "see" an increased impedance from the surrounding epidural fat. This implies that the energy requirements for stimulation in the thoracic region will be higher than in the cervical region, at least during the acute phase of implant.

Technical performance of percutaneous leads for spinal cord stimulation: a modeling study.

Objective To compare the technical performance of different percutaneous lead types for spinal cord stimulation. Methods Using the ut-scs software (University of Twente's spinal cord stimulation), lead models having similar characteristics such as the 3487A PISCES-Quad (PQ), 3887 PISCES-Quad Compact (PC), 3888 PISCES-Quad Plus (PP) (Medtronic Inc., Minneapolis, MN), and the AB SC2108 (AB) (Advanced Bionics Corp., Valencia, CA) were simulated in monopolar and tripolar (guarded cathode) combinations on a single lead, placed just outside the dorsal dura mater and both centered on the spinal cord midline, and at 1 mm lateral. The influence of displacing a lead dorsally in the epidural fat was examined as well. Finally, dual leads both aligned and offset were modeled. Several parameters were calculated to allow a quantitative comparison of the performances. Results When programmed as a guarded cathode, the AB lead recruits nerve fibers in an ~25% larger dorsal column area than the PQ. However, the AB has an ~160% higher energy consumption. The performance of the PC is between the AB and PQ, whereas the PP is suitable only for dorsal root stimulation. Displacing a single lead off midline or dorsally decreases its ability to recruit fibers in the dorsal columns. Similarly, dual lead combinations are less capable when compared to single lead centered on the spinal cord midline just outside the dura mater. Conclusions Complex pain syndromes are treated best with lead having a small contact spacing, being programmed as a tripole (guarded cathode) and centered on the spinal cord midline just outside the dura mater. This is because dorsal column fiber recruitment is more extensive than with any other combinations, including dual leads. Improved recruitment of dorsal column fibers is accompanied by increased energy consumption.

Technical performance of percutaneous and laminectomy leads analyzed by modeling.

The objective of this study was to compare the technical performance of laminectomy and percutaneous spinal cord stimulation leads with similar contact spacing by computer modeling. Monopolar and tripolar (guarded cathode) stimulation with both lead types in a low-thoracic spine model was simulated using UT-SCS software. Dorsal column and dorsal root fiber thresholds were calculated as well as the area of recruited fibers in the dorsal columns, the rostrocaudal span of recruited dorsal root fibers and the energy consumption at discomfort threshold. Tripolar stimulation is superior to monopolar stimulation in the recruitment of the dorsal columns, a percutaneous lead recruits a ∼12% larger dorsal column area than a laminectomy lead does. This difference is reduced when the contact spacing of the lead models is the same. A percutaneous lead with significant wire impedance (140 Ohms) consumes ∼115-240% more energy, whereas the same lead with negligible wire impedance consumes ∼40-85% more energy. A deterioration of all performance parameters is predicted when a percutaneous lead is placed more dorsally in the epidural tissue. When positioned next to the dura mater, a percutaneous lead has a similar performance (fiber recruitment in the dorsal columns and the dorsal roots) as a laminectomy lead with similar contact spacing, but substantially higher energy consumption. The superior clinical performance of the laminectomy lead is most probably due to the difference in volume and insertion technique of the two lead types.