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30 protocols using activa pc

1

Rechargeable IPG Replacement in PD Patients

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In this monocentric cohort study, we prospectively collected data from consecutive PD patients with STN-DBS, who underwent the replacement of an nrIPG (Activa PC* or Kinetra*, Medtronic, Minnesota, USA) by a constant-current rechargeable one (VERCISE RC TM or GEVIA RC TM , Boston Scientific, Massachusetts, USA), in the [BLINDED FOR REVIEW] Hospital from January 2017 to December 2018 (rIPG group). Patients selected for benefiting from a CC-rIPG should have a long-life expectancy promising numerous nrIPG changes in the future, and/or a previous history of surgical site infection and/or a battery lifespan below 2 years. Conversely, we excluded patients who were unable to handle the reloading procedure, mostly because of cognitive impairment. For comparison purposes, we constituted a retrospective reference cohort including all PD patients who underwent in 2016 an IPG replacement using the non-rechargeable device (Activa PC*, Medtronic, Minnesota, USA), at a period when rechargeable devices were not available in our center (nrIPG group).
All nrIPGs were used in CV mode only. The protocol was approved by the local ethics committee of [BLINDED FOR REVIEW]. All patients gave informed consent for the procedure.
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2

Responsive Closed-Loop Adaptive Deep Brain Stimulation

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The responsive (closed loop) aDBS is delivered through a custom-made stimulation-amplifier which allows local field potentials (LFPs) to be recorded during the application of DBS. With this device, LFPs are filtered in real time around a subject’s specific beta frequency (±3 Hz around peak).9 (link) Afterwards, a median threshold is selected in order to deliver monopolar stimulation every time that beta activity in the rectified filtered LFP exceeds the predefined threshold. Stimulation pulses are charge-balanced and asymmetric, mirroring the waveform of the standard clinical Medtronic Activa PC. Pulses are delivered at 130 Hz with a pulse width of 60 µs (standard clinical parameters) using a ramping period of 250 ms at onset and offset in order to help limit the presence of paraesthesias, autonomic or other non-specific side effects, such as dizziness or nausea.25 (link) From the four contacts available for each electrode lead, two electrodes are required to perform bipolar LFP recordings (either contacts 0–2 or 1–3), while one electrode (in between the two recording electrodes) is left available for stimulation (either contact 1 or 2). The stimulation-amplifier has been built to strict safety guidelines (Report 90 BS EN60601-1 safe design, construction of medical equipment) and extensively tested,8 9 11 26 (link) and found to be safe and reliable.
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3

Deep Brain Stimulation in Parkinson's Disease

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Seven patients with PD (4 right-handed and 3 left-handed; 49 to 71 years old, mean = 58.3) underwent bilateral STN-DBS (using the model 3389 quadripolar DBS lead and the Activa-PC® neuropacemaker from Medtronic, Minneapolis, MI, USA). In all cases, the indication for STN-DBS was the presence of severe levodopa-related motor complications. The study population’s baseline characteristics are summarized in Table 1. The inclusion criteria were classical and similar to those defined by the Core Assessment Program for Surgical Interventional Therapies in Parkinson’s disease (CAPSIT-PD). Written informed consent was provided by the patients and the study was approved by the ethics committee (Committee for Personal Protection Nord-Ouest II) according to the guidelines of the Declaration of Helsinki of 1975 (ref ID-RCB 2013-A01297-38).
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4

MRI-Guided Bilateral DBS Implantation

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Bilateral DBS (3389 Medtronic lead) implantation was performed under GA using a stereotactic MRI-guided and MRI-verified approach without microelectrode recording (Leksell frame G, Elekta) as detailed in previous publications (Foltynie et al., 2011 (link); Holl et al., 2010 (link)). Two stereotactic, pre-implantation scans were acquired, as part of the surgical procedure, to guide lead implantation; a T2-weighted axial scan (partial brain coverage around the STN) with voxel size of 1.0×1.0mm2 (slice thickness=2mm) and a T1-weighted 3D-MPRAGE scan with a (1.5mm)3 voxel size on a 1.5T Siemens Espree interventional MRI scanner. Three-dimensional distortion correction was carried out using the scanner’s built-in module. Target for the deepest contact was selected at the level of maximal rubral diameter (~5mm below the AC-PC line). To maximising DBS trace within the STN, the target was often chosen 1.5-2mm posterolateral to that described by Bejjani (Bejjani et al., 2000 (link)). Stereotactic imaging was repeated following lead implantation to confirm placement. A dual channel implantable pulse generator (IPG) (Activa PC, Medtronic, Minneapolis, Minn., USA) was then implanted in the infra-clavicular region on the same day of lead implantation or within a week, as a staged procedure.
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5

Bilateral STN and VC/VS DBS Implantation

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Surgery was performed under general anesthesia. Patients underwent stereotactic 1.5T MRI (Magnetom Avanto; Siemens) for planning of amSTN and VC/VS coordinates and trajectories (12) (link). Through 14-mm frontal bilateral burr holes, 1.5-mm-diameter radiofrequency electrodes were introduced to each target under dynamic impedance monitoring. These were replaced with DBS leads through the same trajectory to the target. Separate corticotomies, within the same burr hole, were used to implant the two DBS leads. Quadripolar DBS leads were used with 0.5-mm separation between contacts for amSTN leads (3389; Medtronic, Minneapolis, MN) and 1.5-mm separation between contacts for VC/VS leads (3387; Medtronic). The VC/VS lead was planned to locate one contact within the nucleus accumbens core, one contact within its shell, and the upper two contacts in the most ventral aspect of the anterior limb of the internal capsule. An immediate stereotactic MRI verified targeting accuracy (13) (link). Two neurostimulators (Activa PC; Medtronic) were placed subcutaneously below the collarbone, one on each side, and each was connected to bilateral leads from one of the electrodes via subcutaneous cables.
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6

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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7

Stereotactic DBS Procedure for VC/VS Targeting

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For a detailed description of our stereotactic DBS procedures, see also previous publications (21, 22, 23). In short, all the surgical procedures were performed under general anesthesia with remifentanil and propofol. A Leksell stereotactic frame (Model G, Elekta Instrument Stockholm, Sweden) was mounted on the skull and a perioperative CT‐scan of the head with frame was acquired and fused with the preoperative MR images using Framelink software (Medtronic, Fridley, USA). The planned target was the VC/VS with the stereotactic coordinates: (−) 6 lateral of the middle of the bi‐commissural line (mid AC‐PC), 12 mm anterior of the mid AC‐PC and −3 mm under the bi‐commissural line. The target was adjusted based on the patient's individual anatomy. Typically, we planned a paraventricular trajectory, along which in the first three patients microelectrode recording was performed. As the VC/VS area showed no typical extracellular electrical activity, microelectrode recording was discontinued thereafter. All patients were finally implanted with bilateral quadripolar electrodes (Model 3387, Medtronic, Fridley, USA) along the central trajectory with variable contact points on target (Table 2) which were subsequently connected to an IPG (Activa PC, Medtronic, Fridley, USA).
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8

Deep Brain Stimulation for Mood Regulation

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Implantation of DBS leads was performed according to standard stereotactic procedures using frame‐based magnetic resonance imaging (MRI) for target determination, under local anesthesia. Participants underwent bilateral implantation of quadripolar 3389 electrodes (Medtronic, Minnesota, USA), spaced 0.5 mm apart and 1.5 mm long (Fig. 2). The surgical target (of the electrode tip) was the NAc as identified on MRI. Stereotactic atlases place this 7 mm lateral to the midline, 3 mm anterior to the anterior border of the anterior commissure, and 4 mm inferior to the intercommissural line. The two ventral contacts were targeted in the center of the NAc (E0, E1, E8, E9). Intra‐operative test stimulation was conducted to assess mood and behavior. The electrodes were connected via subcutaneous extensions to Activa PC, or RC stimulator (Medtronic, Minnesota, USA) placed in the infraclavicular pocket, under general anesthesia. Post‐operative computed tomography (CT) fused with pre‐operative MRI verified the position of the implanted electrodes. DBS was switched on 2 days following the surgery.
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9

Stereotactic DBS Implantation for Parkinson's Disease

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All surgeries performed with preoperative cranial 3.0T MRI and standardized stereotactic procedures. The stereotactic apparatus was Leksell G frame (Elekta). The coordinates calculated and trajectory designed with Medtronic S7 Neuro Navigation System (Medtronic Navigation) to target the STN. Bilaterally Medtronic DBS electrodes (Model 3389 electrode; Medtronic) implanted under local anesthesia and IPG (Activa PC; Medtronic) implanted under general anesthesia. All the operations achieved in 1 day. Postsurgery stimulation parameters were set 4 weeks postoperation and gradually achieved the optimal stimulation parameters in 3 months.
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10

Deep Brain Stimulation Implantation Procedure

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Patients underwent surgical implantation of DBS electrodes (model 3387; Medtronic, Inc.), which were inserted bilaterally through 2 bur holes, followed by the implantation of a dual-channel internal pulse generator (IPG) into the infraclavicular area (Activa PC, Medtronic, Inc.). These were connected via a lead extension (model 37085, Medtronic, Inc.). After surgery, stereotactic MRI was performed, and patients were admitted to the hospital. Patients were seen by the treating neurosurgeon at 2 weeks and again 6 to 12 weeks after the operation. In a separate setting, 2 weeks after the operation, monopolar review was carried out, followed by activation versus no activation of the device in a randomized, double-blind fashion, per the study design. All treating physicians and patients were blinded to the activation status of the IPG. Close clinical follow-up was maintained, as per the study protocol, beyond the perioperative neurosurgical clinic visits.
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