Interventional MRI–guided deep brain stimulation in pediatric dystonia: first experience with the ClearPoint system

Starr, Philip A.; Markun, Leslie C.; Larson, Paul; Volz, Monica; Martin, Alastair J.; Ostrem, Jill L.

doi:10.3171/2014.6.peds13605

Cited by 95 publications

(66 citation statements)

References 29 publications

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“…The main features of the ClearPoint system have been previously described in technical reports. 16,29 The implantable pulse generators (IPGs) and lead extenders were placed in a separate inpatient or outpatient procedure 1-3 weeks after lead implantation.…”

Section: Methods Patient Selection and Clinical Characterizationmentioning

confidence: 99%

“…We have recently reported our experience using the ClearPoint system in a series of primary pediatric dystonia patients (who would also have had difficulty handling awake surgery) who also experienced excellent outcomes. 29 Disadvantages of the iMRI method include the need for specialized MR-compatible instrumentation and anesthesia equipment, as well as access to a scanner in the radiology department or an operating room. At our center, awake DBS cases include IPG placement on the same day, whereas MRI cases require a staged approach with the IPG placed several weeks later as an outpatient procedure.…”

Section: Clinical Applicationmentioning

confidence: 99%

“…16 We recently published our experience using the ClearPoint system to implant DBS electrodes using iMRI in a series of pediatric dystonia patients with excellent outcomes. 29 In this prospective study we describe the use of the ClearPoint system to place DBS leads in adults with PD and report the clinical outcomes 12 months after surgery.…”

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confidence: 99%

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Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson’s disease

Ostrem

Ziman

Galifianakis

et al. 2016

JNS

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124

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(DBS) has been shown to be a highly effective treatment option for medicationrefractory Parkinson's disease (PD) patients experiencing motor fluctuations and dyskinesia. 5,15,18,21,22,26,31 Clinical outcomes with DBS are critically dependent on the exact lead placement in the intended brain target (dorsal lateral subthalamic nucleus [STN] or posterior [motor] area of the internal globus pallidus [GPi]), but surgical methods to achieve acceptable placement are not standardized. The traditional method for DBS lead implantation involves the use of preoperative brain images registered in a stereotactic coordinate system, and physiological localization using microelectrode-guided mapping of the target regions while patients are awake.28 This method poses challenges when patients are not able to tolerate and/or cooperate with awake surgery (severe "off" medication symptoms, anxiety, pain).Recently a new method has been developed for implan- obJective The ClearPoint real-time interventional MRI-guided methodology for deep brain stimulation (DBS) lead placement may offer advantages to frame-based approaches and allow accurate implantation under general anesthesia. In this study, the authors assessed the safety and efficacy of DBS in Parkinson's disease (PD) using this surgical method. methods This was a prospective single-center study of bilateral DBS therapy in patients with advanced PD and motor fluctuations. Symptom severity was evaluated at baseline and 12 months postimplantation using the change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III "off" medication score as the primary outcome variable. results Twenty-six PD patients (15 men and 11 women) were enrolled from 2010 to 2013. Twenty patients were followed for 12 months (16 with a subthalamic nucleus target and 4 with an internal globus pallidus target). The mean UPDRS Part III "off" medication score improved from 40.75 ± 10.9 to 24.35 ± 8.8 (p = 0.001). "On" medication time without troublesome dyskinesia increased 5.2 ± 2.6 hours per day (p = 0.0002). UPDRS Parts II and IV, total UPDRS score, and dyskinesia rating scale "on" medication scores also significantly improved (p < 0.01). The mean levodopa equivalent daily dose decreased from 1072.5 ± 392 mg to 828.25 ± 492 mg (p = 0.046). No significant cognitive or mood declines were observed. A single brain penetration was used for placement of all leads, and the mean targeting error was 0.6 ± 0.3 mm. There were 3 serious adverse events (1 DBS hardware-related infection, 1 lead fracture, and 1 unrelated death). coNclusioNs DBS leads placed using the ClearPoint interventional real-time MRI-guided method resulted in highly accurate lead placement and outcomes comparable to those seen with frame-based approaches.Clinical trial registration no.: NCT00792532 (clinicaltrials.gov)

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Section: Methods Patient Selection and Clinical Characterizationmentioning

confidence: 99%

Section: Clinical Applicationmentioning

confidence: 99%

See 1 more Smart Citation

Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson’s disease

Ostrem

Ziman

Galifianakis

et al. 2016

JNS

Self Cite

124

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“…It has demonstrated high targeting accuracy 16 and clinical outcomes comparable to those for conventional implantation approaches. 15,16 The method allows patients to avoid an awake surgical procedure, making the therapy available to a wider range of cases including pediatric patients. The number of MRI scanners in the United States was 3265 in 1995 and 7810 in 2007, 12 indicating wide system availability for these types of procedures.…”

Section: Discussionmentioning

confidence: 99%

“…The surgical procedure has been described in detail elsewhere. 15,16 Briefly, skin incision was followed by drilling unilateral or bilateral 15-mm frontal bur holes. Bilateral or unilateral trajectory guides (NexFrame, Medtronic, or ClearPoint SmartFrame, MRI Interventions) were fixed over the resulting opening by using temporary bone screws, and the patient was moved to the magnet isocenter.…”

Section: Surgical Team and Proceduresmentioning

confidence: 99%

Deep brain stimulator implantation in a diagnostic MRI suite: infection history over a 10-year period

Martin

Larson

Ziman

et al. 2017

JNS

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10,11,16 Precise electrode placement within a selected brain region is necessary to achieve efficacy, which is traditionally done with frame-based or "frameless" neuronavigation-guided stereotaxy supported by invasive physiological testing including microelectrode recording. Physiological methods can be used to mitigate the accuracy limitations of stereotactic methods that use a skull-mounted frame or other external markers for spatial registration of brain structures to preoperatively acquired images. 2The iMRI DBS electrode implantation technique utilizes bur hole-mounted trajectory guides oriented toward targets that are defined intraoperatively. The entire procedure is performed within the bore of an MR magnet, with the patient's head positioned at the rear magnet opening for surgical exposure and at the magnet isocenter for target identification, device alignment, and insertion monitoring. The primary benefits of the iMRI technique are high targeting accuracy, reduced operative time, and an ability to directly confirm electrode placement during the procedure. In contrast to conventional stereotactic methods, the iMRI approach is performed with the patient under general anesthesia and does not require intraoperative testing of motor symptoms. obJective The objective of this study was to assess the incidence of postoperative hardware infection following interventional (i)MRI-guided implantation of deep brain stimulation (DBS) electrodes in a diagnostic MRI scanner. methods A diagnostic 1.5-T MRI scanner was used over a 10-year period to implant DBS electrodes for movement disorders. The MRI suite did not meet operating room standards with respect to airflow and air filtration but was prepared and used with conventional sterile procedures by an experienced surgical team. Deep brain stimulation leads were implanted while the patient was in the magnet, and patients returned 1-3 weeks later to undergo placement of the implantable pulse generator (IPG) and extender wire in a conventional operating room. Surgical site infections requiring the removal of part or all of the DBS system within 6 months of implantation were scored as postoperative hardware infections in a prospective database. resUlts During the 10-year study period, the authors performed 164 iMRI-guided surgical procedures in which 272 electrodes were implanted. Patients ranged in age from 7 to 78 years, and an overall infection rate of 3.6% was found. Bacterial cultures indicated Staphylococcus epidermis (3 cases), methicillin-susceptible Staphylococcus aureus (2 cases), or Propionibacterium sp. (1 case). A change in sterile practice occurred after the first 10 patients, leading to a reduction in the infection rate to 2.6% (4 cases in 154 procedures) over the remainder of the procedures. Of the 4 infections in this patient subset, all occurred at the IPG site. conclUsions Interventional MRI-guided DBS implantation can be performed in a diagnostic MRI suite with an infection risk comparable to that reported for traditional surgical placement techniqu...

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MRI‐guided stereotactic neurosurgical procedures in a diagnostic MRI suite: Background and safe practice recommendations

Larson

Willie

Vadivelu

et al. 2017

J of Healthc Risk Manag

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The development of navigation technology facilitating MRI-guided stereotactic neurosurgery has enabled neurosurgeons to perform a variety of procedures ranging from deep brain stimulation to laser ablation entirely within an intraoperative or diagnostic MRI suite while having real-time visualization of brain anatomy. Prior to this technology, some of these procedures required multisite workflow patterns that presented significant risk to the patient during transport. For those facilities with access to this technology, safe practice guidelines exist only for procedures performed within an intraoperative MRI. There are currently no safe practice guidelines or parameters available for facilities looking to integrate this technology into practice in conventional MRI suites. Performing neurosurgical procedures in a diagnostic MRI suite does require precautionary measures. The relative novelty of technology and workflows for direct MRI-guided procedures requires consideration of safe practice recommendations, including those pertaining to infection control and magnet safety issues. This article proposes a framework of safe practice recommendations designed for assessing readiness and optimization of MRI-guided neurosurgical interventions in the diagnostic MRI suite in an effort to mitigate patient risk. The framework is based on existing clinical evidence, recommendations, and guidelines related to infection control and prevention, health care-associated infections, and magnet safety, as well as the clinical and practical experience of neurosurgeons utilizing this technology.

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Interventional MRI–guided deep brain stimulation in pediatric dystonia: first experience with the ClearPoint system

Cited by 95 publications

References 29 publications

Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson’s disease

Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson’s disease

Deep brain stimulator implantation in a diagnostic MRI suite: infection history over a 10-year period

MRI‐guided stereotactic neurosurgical procedures in a diagnostic MRI suite: Background and safe practice recommendations

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