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12 protocols using activa rc

1

Stereotactic Implantation of Thalamic Electrodes for Tremor Suppression

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Surgery was performed under local anaesthesia, using the CRW frame, targeting the thalamus with previously acquired MRI scans fused to a stereotactic CT scan. A more detailed account of the surgical methodology employed has been described previously (Papanastassiou et al., 1998 , Orth et al., 1999) . Bilateral Vim thalamic nuclei were implanted with Medtronic 3387 electrodes and their positions confirmed with stereotactic CT imaging.
The target points were also related to the mid commissural point (MCP) as follows: Vim 12mm lateral and 4mm posterior to the MCP. The implanted electrodes were externalised for a period of trial stimulation using Medtronic test stimulator (ENS), following which the electrodes were internalised and connected to an Activa RC implantable pulse generator (Medtronic Inc.). Optimal lead placement for tremor suppression was achieved with the aid of intraoperative stimulation.
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2

Bilateral Subthalamic Nucleus Deep Brain Stimulation Protocol

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All surgeries were performed by the same surgical team. All patients underwent bilateral STN-DBS. The Leksell Stereotactic System (Elekta, Stockholm, Sweden) and Frame Link planning system (Medtronic, Minneapolis, Minnesota, USA) were used for surgery preparation. According to the Schaltenbrand-Wahren atlas, the tentative target site was 2 mm posterior to the midpoint of the anterior–posterior commissure (AC-PC) line, 12 mm lateral to the AC-PC line, and 4 mm ventral to the AC-PC line. Target sites were corrected based on T2-weighted MRI. The target was reconfirmed physiologically by an intraoperative microelectrode recording prior to performing the test stimulation studies. Quadripolar DBS electrodes (Activa 3389s, Medtronic) were implanted bilaterally as a stereotactic guide.
After inducing general anesthesia, implantable pulse generators (Activa RC Medtronic) were implanted subcutaneously in the subclavian pockets of the chest wall and connected to the DBS leads. Postoperative computed tomography images and preoperative MR images were superimposed in the Frame Link planning system to insure the local accuracy of electrode placement.
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3

Canine Atrial Fibrillation Model Development

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The canine AF model was set up as previously reported.4, 5, 11 Twelve adult female beagle dogs (body weight 9.6±0.6 kg) were anesthetized with dormicum (midazolam 0.2 mg/kg, intravenous) and propofol (propofol 6 mg/kg, intravenous), then given isoflurane (isoflurane 2.5%, inhalation) during the surgery. Two pairs of electrodes were sutured against the left atrial (LA) appendage and right atrial free wall and later used for atrial electrogram monitoring and stimulation. The other ends of the electrode wires were tunneled subcutaneously and exposed at the lower back of the neck. For continuous rapid atrial pacing, a unipolar screw‐in lead (OptiSense model 1999; St. Jude Medical, St. Paul, MN, USA) was inserted through the right external jugular vein and the distal end of the lead was screwed into the endocardial side of the right atrial appendage. The proximal end of the pacing lead was connected to a rapid pulse generator (Activa RC; Medtronic, Minneapolis, MN, USA), which was implanted into a subcutaneous pocket at the upper back of the neck. Atrioventricular block was not performed in this study to mimic the hemodynamic situation of clinical cases of AF.4, 5, 11 All study protocols were performed in accordance with the guidelines specified by the Animal Experimentation and Ethics Committee of the Kitasato University School of Medicine.
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4

Deep Brain Stimulation Procedure

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The general surgical procedure has been published in detail before. Patients are operated under local anesthesia with sedation (remifentanil and propofol).
In summary, after fixation of the stereotactic frame (CRW Stereotactic System, Integra Neurosciences, or Riechert-Mundinger frame), planning is performed on fused stereotactic CT/MRI images, with the Framelink (Medtronic Inc.) or STP 3.5 (Leibinger) planning station.
The trajectory is planned so that both VIM and PSA can be stimulated, with one electrode contact on the AC-PC level. Macrostimulation is performed in all patients. Microrecording is selected in a number of patients based on the surgeon’s preference. Implanted electrodes are quadripolar electrodes from Medtronic Inc. (model 3387 or 3389) or octopolar electrodes from Boston Scientific (model 616010).
Finally, the pulse generator (Activa PC, model 37601; Activa RC, model 37612, Medtronic, USA or Vercise, Boston Scientific, USA) is implanted subcutaneously in the infraclavicular or lateral abdominal region under general anesthesia.
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5

Bilateral Deep Brain Stimulation Targeting

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When selecting GPi or STN as the target, each patient’s profile was carefully evaluated including motor symptoms, non-motor symptoms and medications, especially severity of dyskinesias, dystonia, axial symptoms, cognition and mood problems (Ramirez-Zamora and Ostrem, 2018 (link)). All patients underwent 3.0 Tesla MRI before surgery. We applied the Leksell stereotactic frame to the patient’s head followed by a head CT scan. The specific target coordinates and trajectory were defined using the SurgiPlan system after the coregistration of MRI-CT images, targeting the posterior GPi. All patients were implanted bilaterally with DBS leads simultaneously (model 3,387; Medtronic, Minneapolis, MN, USA) under general anesthesia. The implantable pulse generators (Activa RC, Medtronic, Minneapolis, MN, USA) were placed subclavicularly and connected with electrodes via subcutaneous wires at the same day. Postoperative head CT scan was performed and the image study was fuse to the preoperative targeting MRI to confirm satisfactory electrode placement of DBS leads and absence of complications. Each patient was carefully programmed monthly within the first half year after surgery to achieve optimal stimulation settings, and was followed by regular visits every 3 months or as clinically indicated.
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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

Implantable Stimulator Electrode Tunneling

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A total of 10–14 days after the second-phase surgery, extension leads (Medtronic 7483) are tunneled from the buried ends of the intracranial electrodes to implanted stimulators (Medtronic Activa RC or PC) placed in the chest. In order to facilitate programming with differing frequencies in different targets, homologous leads are routed to the same stimulator, typically with both GPi leads connected to the stimulator in the left chest, and both thalamic (or other target) leads connected to the stimulator in the right chest.
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8

Spinal Cord Stimulation for SCI Patients

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Experiments conducted in human subjects with SCI were carried out
within the framework of an ongoing clinical study (ClinicalTrials.gov
Identifier: NCT02936453) that has been approved by Swiss authorities
(Swissethics protocol number 04/2014 ProjectID: PB_2016-00886, Swissmedic
protocol 2016-MD-0002), and were in compliance with all relevant clinical
regulations. The study is conducted at the Lausanne University Hospital
(CHUV). All subjects signed written inform consent prior to their
participation. The subjects were surgically implanted with a spinal cord
stimulation system comprising an implantable pulse generator (Activa™
RC, Medtronic plc, Fridley, Minnesota, SA) connected to a 16-electrode
paddle array (Medtronic Specify™ 5-6-5 surgical lead) that was placed
over the lumbosacral segments of the spinal cord. Subject related data and
details on their neurological status at their entry into the clinical study,
evaluated according to the International Standards for Neurological
Classification of Spinal Cord Injury, are provided in the Life Sciences
Reporting Summary and in Supplementary Table 1. Subjects’ recruitment process is
described in the Life Sciences Reporting Summary.
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9

Spinal Cord Stimulation for SCI Patients

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Experiments conducted in human subjects with SCI were carried out
within the framework of an ongoing clinical study (ClinicalTrials.gov
Identifier: NCT02936453) that has been approved by Swiss authorities
(Swissethics protocol number 04/2014 ProjectID: PB_2016-00886, Swissmedic
protocol 2016-MD-0002), and were in compliance with all relevant clinical
regulations. The study is conducted at the Lausanne University Hospital
(CHUV). All subjects signed written inform consent prior to their
participation. The subjects were surgically implanted with a spinal cord
stimulation system comprising an implantable pulse generator (Activa™
RC, Medtronic plc, Fridley, Minnesota, SA) connected to a 16-electrode
paddle array (Medtronic Specify™ 5-6-5 surgical lead) that was placed
over the lumbosacral segments of the spinal cord. Subject related data and
details on their neurological status at their entry into the clinical study,
evaluated according to the International Standards for Neurological
Classification of Spinal Cord Injury, are provided in the Life Sciences
Reporting Summary and in Supplementary Table 1. Subjects’ recruitment process is
described in the Life Sciences Reporting Summary.
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10

Stereotactic Deep Brain Stimulation for Dystonia

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Surgery was performed under isofluorane general anesthesia, in view of the young age of the children. Stereotactic MRI was performed pre-operatively under anesthesia with a Leksell G Frame in place to determine co-ordinates targeted in the postero-latero-ventral GPi. Bilateral electrodes were implanted in each case. The electrodes used are all Medtronic 3389 circumferential electrodes: contacts 0.5 mm apart and 1.5 mm in length. Final electrode placement was confirmed by post-operative stereotactic CT scan, under the same general anesthetic, fused with the intra-operative in-frame pre-surgical MRI. The pulse generator was then inserted (Soletra and Kinetra until 2008, and Activa RC pulse generators thereafter, Medtronic, Minneapolis, MN, USA).
Accuracy of electrode placement within our service has been studied previously (22 (link)). Mean Euclidean distance between final electrode tip position and target position was 2.2 mm with no difference in accuracy between isolated genetic/idiopathic and acquired dystonia cases. No correlation was found between outcome at 1 year and Euclidian distance between target and actual position (22 (link)).
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