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28 protocols using model 3389

1

Cortical Signatures of Respiratory Dynamics

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In patients with externalized electrodes, it was possible to simultaneously record local field potentials (LFPs) during resting breathing and forced respiratory maneuvers in the OFF stimulation state. As a control, LFPs were recorded during the same conditions from patients with GPi electrodes, as this nucleus has previously not produced changes in lung function when stimulated.9 Recordings were made from adjacent contacts of each deep brain macroelectrode (Medtronic, model 3389) in a bipolar configuration. Signals were filtered at 0.5–500 Hz and amplified (10,000x) using isolated CED 1902 amplifiers and digitized using CED 1401 Mark II at a rate of 2.5 kHz (Cambridge Electronic Design, Cambridge, UK). LFPs were displayed online and saved onto hard disk using Spike II (CED) and subsequently analyzed offline. Fast Fourier Transformations were applied to decompose the LFP signal into its constituent frequencies, specifically the 7–11 Hz band, although the full power spectrum was reviewed for the presence of artifact prior to filtering. Mean power within the 7–11 Hz band during forced respiratory maneuvers across all trials was compared to mean 7–11 Hz band power during randomly selected periods of resting breathing.
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2

Spectral Changes in STN of Parkinson's Patients

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We investigated spectral states in the STN LFP before and after administration of levodopa in 32 patients (64 hemispheres) with advanced Parkinson’s disease undergoing DBS surgery targeting the STN. Patients had an average age of 58.5 years (range 34–79 years) and an average disease duration of 11.7 years (range 5–18 years). Twelve were female (Supplementary Table 1). All patients were diagnosed with Parkinson’s disease according to the Queen Square Brain Bank criteria.30 (link)
The mean of the part III of the Unified Parkinson’s Disease Rating Scale (UPDRS) score OFF medication was 37.9 (range 15–72) while the mean score ON medication was 14.4 (range 3–30). The DBS electrodes were model 3389 (Medtronic) with four platinum–iridium cylindrical surfaces of 1.27 mm diameter, 1.5 mm length and 2 mm centre-to-centre separation. The contacts were numbered 0 (lowermost) to 3 (uppermost). Correct placement of the DBS electrodes was confirmed by intraoperative microelectrode recordings in 18 patients and by postoperative imaging in all patients. All experimental procedures had received prior approval from the local research ethics committee in accordance with the standards set by the Declaration of Helsinki, and patients gave their written informed consent.
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3

Stereotactic Deep Brain Stimulation Implantation

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The standard surgical procedure was as previously described [19 (link),20 (link)]. Briefly, quadripolar DBS electrodes (model 3389, Medtronic, Minneapolis, MN, USA, or model L301, Pins Medical, Beijing, China) were implanted under the guidance of a Leksell microstereotactic system (Elekta Instrument AB, Stockholm, Sweden) with pre-surgical MRI under local anesthesia. Intra-operative single-unit recordings and high-frequency stimulation testing were performed to evaluate the optimal locations for permanent electrode implantation. The STN target coordinates for the lower contact were 2–3 mm posterior to the MCP, 12–14 mm lateral to the AC-PC, and 4–6 mm below the inter-commissural line. The electrodes were then connected to an implantable pulse generator implanted in the subclavicular area in patients under general anesthesia. We performed post-operative CT to exclude intracranial hemorrhage, then merged the images with the preoperative MR images to verify the exact locations of the electrodes.
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4

Deep Brain Stimulation Electrode Implantation

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The surgical procedure was described in detail in previous reports of studies
conducted in our center.18 (link),24 (link),25 (link) DBS electrode (model
3389, Medtronic, Minneapolis, USA, or model L301, Pins Medical, China; both
electrodes share the same parameters) implantations were performed under local
anesthesia, using a Leksell stereotactic system (Elekta Instrument AB,
Stockholm, Sweden). Electrodes were then connected to an IPG which was implanted
in the subclavicular area under general anesthesia. One month after the
operation, the IPG was turned on and programmed. To clarify the effect of pure
MLE, all the patients did not receive any preceding STN-DBS stimulation in
1 month after the surgery, and all the clinical assessments were completed
before the IPG activation. DBS was activated within the range of 1.5–2.0 V as
standard parameters.26 (link)
The contacts on each electrode were tested, and the best stimulation
parameters were selected when the patient achieved satisfactory improvement with
minimal side effects.
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5

Deep Brain Stimulation in Parkinson's Disease

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A total of 15 patients with PD who underwent bilateral implantation of DBS electrodes in the STN were included in the study (see Supplementary Table 1). Informed consent was obtained before inclusion in the study, which was approved by the local ethics committee in accordance with the standards set by the Declaration of Helsinki. The DBS electrode used was model 3389 (Medtronic) connected to an Activa PC+S (Medtronic) implanted pulse generator. Correct placement of the DBS electrodes was confirmed by intraoperative microelectrode recordings and postoperative MRI in all patients. Contacts 0 and 3 were the lowermost and uppermost contacts, respectively. Contacts used to obtain bipolar recordings of the LFP reported in this study were the 2 contacts surrounding the contact, which had proven to be clinically most efficient in the months after neurostimulator implantation.
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6

Bilateral STN-DBS Implantation Protocol

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Bilateral STN‐DBS implantations were conducted using a Leksell G frame system with the assistance of a Leksel Surgiplan workstation (Elekta Instrument AB, Stockholm, Sweden) with preoperative magnetic resonance imaging and computed tomography. Micro‐electrode recordings and macro‐stimulation were used to accurately target the STN. During electrode implantation, the steel cannulas were kept in place. Quadripolar DBS electrodes (Model 3389; Medtronic; Model L301; PINS Medical; using the same parameters) were implanted and fixed, and the implanted pulse generator was then implanted.
After 4–5 weeks (1 month post‐operation), the patients were asked to return to the hospital to start the program (in a stable off medication condition), to minimize micro‐subthalamotomy effects.13 Each patient underwent a regular adjustment of stimulation settings, achieving satisfactory clinical outcomes and avoiding intolerable side effects. The clinical symptoms were measured, and then each patient underwent a regular adjustment of stimulation settings and medications until optimal control of symptoms was established, followed by a chronic stage clinical evaluation (12 ± 1 months post‐operation).
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7

Deep Brain Stimulation for Parkinson's Disease

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Before the surgery, each patient underwent a nonstereotactic brain magnetic resonance imaging scan and a stereotactic brain computed tomography (CT) scan, which were then fused together to facilitate trajectory planning. As previously reported, implantation of electrodes (Model 3389; Medtronic, MN, USA) into STN was carried out under local anesthesia, with the ideal target determined by the microelectrode recording and intraoperative stimulation. The implantable pulse generator (IPG) (Kinetra, Medtronic) was implanted under general anesthesia. The final position of the electrodes was confirmed with a brain CT scan the next day. When the battery of the IPG wore off 4–5 years after the surgery, a new rechargeable (Activa RC, Medtronic) or nonrechargeable IPG (Activa PC, Medtronic) was replaced.
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8

Intra-operative LFP Recordings in Parkinson's Disease

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Intra-operative LFP recordings were collected in the operating room immediately after DBS lead (model 3389, Medtronic, Inc., Minneapolis, MN, USA) implantation in twenty-eight subthalamic nuclei from seventeen subjects with PD, off medication. All subjects signed a written consent for the study, and the study as well as the patient consent form were approved by the Stanford Institutional Review Board. The pre-operative selection criteria and assessment of subjects have been previously described [7 (link),28 (link),42 (link)]. Long-acting dopaminergic medication was withdrawn over twenty-four hours before and short-acting medication was withdrawn over twelve hours prior to DBS lead implantation. LFP recordings were taken after the therapeutic effectiveness of the DBS lead placement was verified by the absence of adverse effects and an improvement in motor signs [7 (link),43 (link)]. Subjects were awake and not on any benzodiazepine medication.
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9

Deep Brain Stimulation for Parkinson's Disease

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A total of 15 patients with PD who underwent bilateral implantation of DBS electrodes in the STN were included in the study (see Supplementary Table 1). Informed consent was obtained before inclusion in the study, which was approved by the local ethics committee in accordance with the standards set by the Declaration of Helsinki. The DBS electrode used was model 3389 (Medtronic) connected to an Activa PC+S (Medtronic) implanted pulse generator. Correct placement of the DBS electrodes was confirmed by intraoperative microelectrode recordings and postoperative MRI in all patients. Contacts 0 and 3 were the lowermost and uppermost contacts, respectively. Contacts used to obtain bipolar recordings of the LFP reported in this study were the 2 contacts surrounding the contact, which had proven to be clinically most efficient in the months after neurostimulator implantation.
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10

Intraoperative Recording and Stimulation for Deep Brain Stimulation

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The ECOG potentials were recorded using an intraoperative electrophysiology recording system (Guideline 4000 [FHC] or MicroGuide Pro [Alpha Omega]). Recordings were obtained from 5 contacts differentially referenced to the most anterior sixth contact, with a scalp needle electrode as ground. Signals were band-pass filtered at 1 to 500 Hz, amplified, and sampled at a minimum 1000 Hz (Guideline 4000) or 3000 Hz (MicroGuide Pro), with additional notch filtering to remove power line artifacts. The Guideline 4000 system had slight attenuation up to 20 Hz owing to the slow rolloff characteristics of an intrinsic 1-Hz high-pass filter, which was compensated for using an empirically determined correction factor.10 (link) Intraoperative STN stimulation was performed through the DBS lead (model 3389; Medtronic, Inc) using an analog neurostimulator (model 3625; Medtronic, Inc) and a bipolar configuration (contact 0 or 1 was negative; contact 2 or 3 was positive; amplitude, 4 V; pulse width, 60 microseconds; and frequency, 180–200 Hz).
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