Patients with TS underwent presurgical preparation in the Department of Neurosurgery. DBS electrodes (Medtronic 3387) were placed both in the posteroventral lateral GPi and in the thalamic CM/Voi bilaterally, during general anesthesia in the frame of the clinical study protocol. Electrode placement was guided via CT-stereotactic surgery refined by microelectrode recording. In a second step, a dual channel implantable pulse generator (Kinetra, Medtronic) was implanted in the subclavicular region with a switch allowing to connect all four electrodes. Stimulation conditions of the electrodes (SHAM, GPi, and CM/Voi) were applied in a randomized order according to the study protocol (Figure 1 ). Prior to programing of DBS settings, thresholds for any stimulation-induced side effects were determined to allow blinding of the patient with subsequent subthreshold chronic stimulation. Each condition lasted 3 months to allow for stable adjustment. Patients and clinical investigators were blinded to the stimulation condition.
Kinetra
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The Kinetra is a lab equipment product developed by Medtronic. It is designed to perform specific functions within a laboratory setting. The core function of the Kinetra is to facilitate laboratory processes, but a detailed description cannot be provided while maintaining an unbiased and factual approach.
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12 protocols using kinetra
1
Bilateral Deep Brain Stimulation for Tourette's Syndrome
2
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.
3
Stereotactic Deep Brain Stimulation Procedures
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One day before surgery, all patients underwent a brain MRI scan. On the day of surgery, a brain computed tomography (CT) scan with a Leksell G frame (Elekta AB, Stockholm, Sweden) mounted on the skull was performed before surgery. The CT image was then fused to the MRI scan using Stereotactic Planning Software (iPlan, Brainlab, Feldkirchen, Germany) for target determination and trajectory planning. Implantation of electrodes was performed under local anesthesia, under stereotactic guidance and microelectrode recording (MER) technique. The quadripolar leads (Model 3389, Medtronic, Minneapolis, MN, USA) were inserted into target position if satisfactory signals from MER were obtained. Intraoperative test stimulation was performed to monitor improvements of Parkinsonian signs and stimulation-induced side effects. After ensuring accurate electrode placement, the leads were secured at the burr-hole site with an anchoring device (Stimloc, Medtronic, Minneapolis, MN, USA). A similar procedure was repeated on the opposite side. Finally, an IPG (Kinetra, Medtronic, Minneapolis, MN, USA) was implanted subcutaneously in the right sub-clavicular area and connected to extended leads under general anesthesia.
4
Deep Brain Stimulation Surgery Protocol
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DBS surgery was performed as described by Toft et al. [17 (link)]. Briefly, cerebral MRI scanning was performed before the CRW stereotactic frame was mounted for stereotactic 3D CT imaging. CT images were fused with the MRI, and the trajectories and surgical targets were then planned. Target location for the permanently implanted electrodes was further refined intraoperatively using a combination of microelectrode recordings and intraoperative test stimulation. Entry points were set in a parasagittal location and anterior to the coronal suture, placing the trajectories so that they passed through the prefrontal cortex and avoided sulci, ventricles, and vessels. This is in accordance with other series [18 (link), 19 (link)]. The electrodes were fixed to the skull, the extension leads were connected, and a Kinetra or Activa (Medtronic, MN, USA) neurostimulator was implanted. To control for surgically induced trauma or bleeding, all patients received a CT scan within 48 hours of surgery. The results of the CT scans did not reveal any significant hemorrhage or edema along the course of the electrodes.
5
Precision Deep Brain Stimulation Targeting
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Five microelectrodes were introduced simultaneously. The trajectory judged to be located in the dorsolateral part of the nucleus and yielding the longest depth of good STN signals was chosen for clinical test stimulation. Test stimulation was then done as described above for the sMER patients. The trajectory with the best therapeutic window was used for the permanent electrode. The neurostimulator (Kinetra or Activa PC, Medtronic) and connection cables were implanted under general anesthesia. A postoperative CT was performed the next day.
6
Stereotactic Implantation of Deep Brain Stimulation Electrodes
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On the day prior to surgery, all patients underwent a brain MRI scan. A Leksell G‐frame (Elekta AB) was secured to the skull during the preoperative brain CT scan. Subsequently, the CT image was merged with the MRI image for each patient using stereotactic planning software (iPlan, Brainlab) to determine the target and plan the trajectory. Electrode implantation was performed using stereotactic guidance and microelectrode recording (MER) technique under local anesthesia. The quadripolar leads (model 3389, Medtronic) were inserted at the target positions once satisfactory signals were obtained from MER. Intraoperative experimental stimulation was performed to evaluate the improvement in PD symptoms and stimulation‐related side effects. After confirming accurate placement of the electrode, the lead was secured with a fixation device (Stimloc, Medtronic) to the drilled site. The implantation of leads on the opposite side was conducted using the same procedure. Finally, an IPG (Kinetra, Medtronic) was subcutaneously implanted in the right subclavicular area and connected to the extended leads under general anesthesia (Jiang et al., 2015 (link)).
7
EMG Analysis of Parkinson's DBS Adjustment
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The study was approved by the Research Ethics Committee of the Northern Savo Hospital District. All patients provided written informed consent before the measurement. An EMG measurement was performed for 13 patients with advanced PD to observe the muscle activation patterns while adjusting the DBS. The demographics of the patients are presented in Table 1 . The patients had implanted STN-DBS (Kinetra or Activa PC Neurostimulator, Medtronic Inc, Minneapolis, USA) because of severe motor fluctuations, wearing off phases, dyskinesias, tremor, or rigidity. At the time of measurement, the age of the patients was (58 ± 11) (mean ± SD) and the duration from diagnosis (11 ± 5) years. The severity of the motor symptoms was assessed with UDPRS-III motor in the range of 0 − 108. Patients’ UPDRS-III motor score with DBS off was (36 ± 12) and motor score with DBS on was (23 ± 8). The patients continued to have their current antiparkinsonian medication throughout the measurement. The measurements were performed at the BioMag laboratory, Helsinki, by an experienced neurologist (adjustment of DBS, assessment of UPDRS-III), and a physicist (EMG recordings).
8
Deep Brain Stimulation Implantation Technique
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Bilateral DBS leads were implanted under general anaesthesia based on the guide tube/stylette method previously described by others20 (link) (neuroguide™ system, Renishaw, UK). A plastic guide tube cut 12 mm shorter than the planned trajectory length was inserted stereotactically towards the target over a rigid probe and bonded to the skull with acrylic bone cement. A plastic stylette was inserted through each guide tube along the planned trajectory and its location verified with intra-operative stereotactic imaging in the frame (volumetric gadolinium-enhanced T1-weighted MRI scan for the first ten patients, and volumetric CT scan for the remainder). If targeting accuracy on the intra-operative imaging study was deemed satisfactory, the stylettes were removed and DBS leads were passed down the guide tubes to exactly the same depth and connected via extension leads to a pulse generator (Activa PC or Kinetra, Medtronic, USA) subcutaneously implanted in the chest or abdominal wall.
9
Bilateral STN-DBS for Parkinson's
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Twenty Parkinsonian patients treated with bilateral STN-DBS were recruited for the study, with a minimum of 1 year of follow-up after the operation. They had Kinetra and Activa PC stimulator implants with leads No. 3389 (Medtronic plc.). Dementia and musculoskeletal diseases leading to disabilities were exclusion criteria. The patients signed an informed consent form according to the Declaration of Helsinki. The Medical Research Council in Hungary has provided ethical approval (080958/2015/OTIG). The study protocol is summarized in Fig. 1 .![]()
Study protocol.
10
Epidural Motor Cortex Stimulation Protocol
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The surgical procedure was performed with patients under total intravenous anesthesia: a quadripolar electrode strip (model Resume; Medtronic Inc, Minneapolis, Minnesota) was epidurally placed over M1 (through a burr hole over, contralateral to the most affected body side in three patients and bilaterally in remaining patients) and connected to a Soletra or Kinetra (Medtronic Inc) implantable pulse generator (IPG) located in the subclavian region. In all patients, contacts were oriented along the craniocaudal axis of the precentral gyrus: contact 3 was 2 to 3 cm from midline, contact 0 was 4 cm more lateral (Figure 1 ). Implantation site was preoperatively defined (using magnetic resonance imaging and neuronavigation) and verified by means of motor-evoked potentials and by identifying N20-P20 phase reversal of somatosensory evoked potentials obtained from contralateral median nerve stimulation [22 (link)]. Patients postoperatively underwent a computed tomography scan to confirm that the electrode paddle was correctly placed and to rule out surgical complications.
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