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In this study, a new system was evaluated for implanting deep-brain stimulators based on a one-piece platform for each trajectory customized from a preoperative planning image. During surgery, the platform is attached to skull-implanted posts that extend through the scalp. The platform acts as a miniature stereotactic frame to provide guidance for...
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... pixels ranging in size from 0.49 to 0.62 mm, slice thickness = 2 mm for 1 patient, 1.3 mm for 2 pa- tients, 1 mm for all others.) The corresponding points are brought into registration by means of a rigid-body transformation deter- mined using a standard algorithm (algorithm 8.1, 8). The determi- nation of the electrode centroid, point (d) in fi gure 7 is accom- plished by means of an algorithm designed especially for the elec- trodes employed in this study and reported on earlier [13] . ...
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Citations
... Furthermore, when comparing the risk of bone marker dislodgement with patients where the traditional stereotactic frame becomes disconnected from the skull, our findings indicate that the STarFix MTP system offers a level of stability and precision that is on par with other established systems, as supported by studies by Fitzpatrick et al. in 2005 and Ball et al. in 2020 [38,39]. ...
... In summary, our study and the referenced research by [4,38,39]. This technology is evidently a valuable asset for neurosurgeons seeking to conduct accurate and successful DBS surgeries. ...
Background
Deep brain stimulation (DBS) is a well-established and highly effective treatment for patients with medically uncontrolled Parkinson’s disease (PD). This study presents the outcome of patients with PD after subthalamic deep brain stimulation (STN DBS) using the microtargeting the platform (MTP) stereotactic system (the STarFixSystem, FHC Inc., Bowdoin, Me., USA) for accurate localization of the target and precise placement of DBs electrodes. Patients were evaluated preoperatively and the follow up period was 1 year utilizing the Unified Parkinson’s Disease Rating Scale (UPDRS II and III) in on and off medication-stimulation conditions. It included 18 STN DBS procedures in 10 patients over a 2-year period. The technical features and the practical application of the STarFix system and the clinical outcome are reported. Also lead location analysis is done by doing postoperative CT to evaluate the clinical accuracy of the stereotactic system.
Results
The mean age of PD patients was 67.7 years. Six patients were males (60%) and 4 patients were females (40%). The mean postoperative improvement in ADL was 83.47 ± 2.39 over Dopa therapy alone. The mean postoperative improvement in UPDRs motor score was 78.96 ± 7.74 over Dopa therapy alone. The STarFix system showed high accuracy with target error 1.89 mm (SD 0.8) without accounting for brain shift.
Conclusion
Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) offers fundamental benefits for patients with advanced Parkinson’s disease (PD). The usage of the STarFix system for implanting DBS electrodes in the STN provides an accurate, safe, and effective alternative to traditional stereotactic techniques. This approach simplifies the surgical procedure, boosts patient comfort, and minimizes the duration of the operation.
Clinical trial registration ClinicalTrials.gov identifier: NCT03562403. Registered 19 June 2018, https://classic.clinicaltrials.gov/ct2/show/NCT03562403 .
... Similarly, the material (PA12) with a heat deflection temperature of 175 • C at 0.45 MPa [16] is designed for steam sterilization. In vivo studies show an accuracy from 2.0 mm ± 0.9 mm [10] up to 2.8 mm ± 0.84 mm [28]. According to an in vitro study, the accuracy increases to 0.42 mm ± 0.15 mm at 31 virtual target points on a model [29]. ...
The use of stereotactic frames is a common practice in neurosurgical interventions such as brain biopsy and deep brain stimulation. However, conventional stereotactic frames have been shown to require modification and adaptation regarding patient and surgeon comfort as well as the increasing demand for individualized medical treatment. To meet these requirements for carrying out state-of-the-art neurosurgery, a 3D print-based, patient-specific stereotactic system was developed and examined for technical accuracy. Sixteen patient-specific frames, each with two target points, were additively manufactured from PA12 using the Multi Jet Fusion process. The 32 target points aim to maximize the variability of biopsy targets and depths for tissue sample retrieval in the brain. Following manufacturing, the frames were measured three-dimensionally using an optical scanner. The frames underwent an autoclave sterilization process prior to rescanning. The scan-generated models were compared with the planned CAD models and the deviation of the planned target points in the XY-plane, Z-direction and in the resulting direction were determined. Significantly lower (p < 0.01) deviations were observed when comparing CAD vs. print and print vs. sterile in the Z-direction (0.17 mm and 0.06 mm, respectively) than in the XY-plane (0.46 mm and 0.16 mm, respectively). The resulting target point deviation (0.51 mm) and the XY-plane (0.46 mm) are significantly higher (p < 0.01) in the CAD vs. print comparison than in the print vs. sterile comparison (0.18 mm and 0.16 mm, respectively). On average, the results from the 32 target positions examined exceeded the clinically required accuracy for a brain biopsy (2 mm) by more than four times. The patient-specific stereotaxic frames meet the requirements of modern neurosurgical navigation and make no compromises when it comes to accuracy. In addition, the material is suitable for autoclave sterilization due to resistance to distortion.
... In addition to the advantages listed in Table 1, the reduction of inaccuracies due to motion artifacts and the simultaneous supply of both cerebral hemispheres can be mentioned as advantages of this system [16]. Another positive effect is the reduction of the duration for electrode placement by approximately one hour [2,23]. ...
The aim of the project was to develop a patient-specific stereotactic system that allows simultaneous and thus time-saving treatment of both cerebral hemispheres and that contains all spatial axes and can be used as a disposable product. Furthermore, the goal was to reduce the size and weight of the stereotactic system compared to conventional systems to keep the strain on the patient, who is awake during the operation, to a minimum. In addition, the currently mandatory computed tomography should be avoided in order not to expose the patient to harmful X-ray radiation as well as to eliminate errors in the fusion of CT and MRI data.
3D printing best meets the requirements in terms of size and weight: on the one hand, the use of plastic has considerable potential for weight reduction. On the other hand, the free choice of the individual components offers the possibility to optimize the size and shape of the stereotactic system and to adapt it to the individual circumstances while maintaining the same precision. The all-in-one stereotactic system was produced by means of the Multi Jet Fusion process. As a result, the components are highly precise, stable in use, lightweight and sterilizable. The number of individual components and interfaces, which in their interaction are potential sources of error, was significantly reduced. In addition, on-site manufacturing leads to faster availability of the system.
Within the project, a patient-specific stereotaxy system was developed, printed, and assembled, which enables the execution of deep brain stimulation via only three bone anchors located on the skull. Pre-developed MRI markers, which can be screwed directly onto the bone anchors via the sleeves, eliminate the need for a CT scan completely. The fusion of the data, which is no longer required, suggests an improvement in target accuracy.
... Frame-based stereotactic biopsy has long been the gold standard for diagnosing intracranial lesions due to its efficacy and safety (1,5,6). However, traditional stereotaxy has disadvantages, such as cumbersome stereotactic frames, space requirements, and limited scope of application in children (7,8). ...
Introduction
Frame-based stereotactic biopsy is well-established to play an essential role in neurosurgery. In recent years, different robotic devices have been introduced in neurosurgery centers. This study aimed to compare the SINO surgical robot-assisted frameless brain biopsy with standard frame-based stereotactic biopsy in terms of efficacy, accuracy and complications.
Methods
A retrospective analysis was performed on 151 consecutive patients who underwent stereotactic biopsy at Chongqing Sanbo Jiangling Hospital between August 2017 and December 2021. All patients were divided into the frame-based group (n = 47) and the SINO surgical robot-assisted group (n = 104). The data collected included clinical characteristics, diagnostic yield, operation times, accuracy, and postoperative complications.
Results
There was no significant difference in diagnostic yield between the frame-based group and the SINO surgical robot-assisted group (95.74 vs. 98.08%, p > 0.05). The mean operation time in the SINO surgical robot-assisted group was significantly shorter than in the frame-based group (29.36 ± 13.64 vs. 50.57 ± 41.08 min). The entry point error in the frame-based group was significantly higher than in the robot-assisted group [1.33 ± 0.40 mm (0.47–2.30) vs. 0.92 ± 0.27 mm (0.35–1.65), P < 0.001]. The target point error in the frame-based group was also significantly higher than in the robot-assisted group [1.63 ± 0.41 mm (0.74–2.65) vs. 1.10 ± 0.30 mm (0.69–2.03), P < 0.001]. Finally, there was no significant difference in postoperative complications between the two groups.
Conclusion
Robot-assisted brain biopsy becomes an increasingly mainstream tool in the neurosurgical procedure. The SINO surgical robot-assisted platform is as efficient, accurate and safe as standard frame-based stereotactic biopsy and provides a reasonable alternative to stereotactic biopsy in neurosurgery.
... • La fusión de imágenes entre resonancia magnética cerebral estereotáctica y la tomografía cerebral estereotáctica con el marco fijado al cráneo del paciente y marcadores fiduciales, procedimiento que permite usar la alta resolución anatómica de la resonancia y la alta precisión geométrica de la tomografía (Fitzpatrick et al., 2005;O'Gorman et al., 2009;Pezeshkian et al., 2011;Smith and Bakay, 2011). ...
En la implantación de electrodos cerebrales profundos el gran reto del cirujano es la más precisa implantación de electrodos en el lugar seleccionado, presentamos el análisis de la técnica quirúrgica estándar internacional y análisis de una cohorte de pacientes implantados en términos de precisión lograda en un estudio observacional descriptivo retrospectivo de doce pacientes, se analizó la precisión en implantación de electrodos con la técnica quirúrgica estándar internacional, comparando la posición de los electrodos en el post operatorio inmediato con la posición de los electrodos planeada antes del procedimiento quirúrgico. El estudio incluye doce pacientes con Enfermedad de Parkinson (9), distonía cervical (1), síndrome tardío (1) y Enfermedad de Gilles de la Tourette (1), implantados con técnica quirúrgica estándar internacional. Todos los pacientes fueron implantados bilateralmente, para un total de 24 electrodos implantados. En la medición de la distancia entre el blanco quirúrgico planeado en el preoperatorio y la localización final del electrodo, encontramos una distancia promedio de 0.89 milímetros, con un rango entre 0 y 2.5 milímetros. Encontramos que la implantación de electrodos cerebrales por estereotaxia, imágenes, software y microregistro, en paciente despierto, con micro y macro estimulación, es un procedimiento preciso y seguro con diferencia promedio 0,89 milímetros.
... Existing standards of care for guiding electrode placement include intraoperative cone-beam CT (CBCT) or magnetic resonance imaging (MRI), frame-based stereotaxy (Fitzpatrick et al 2005), surgical navigation with infrared (IR) or electromagnetic (EM) trackers (Nowell et al 2014), and (more recently) surgical robotics (Dorfer et al 2017). With the exception of direct visualization in real-time MRI, such systems largely assume rigidity with respect to the skull and are susceptible to geometric errors resulting from intracranial tissue deformation and bending of the electrode array (delivered via a long, thin wire). ...
Purpose:
Accurate neuroelectrode placement is essential to effective monitoring or stimulation of neurosurgery targets. This work presents and evaluates a method that combines deep-learning and model-based deformable 3D-2D registration to guide and verify neuroelectrode placement using intraoperative imaging.
Methods:
The registration method consists of three stages: (1) detection of neuroelectrodes in a pair of fluoroscopy images using a deep learning approach; (2) determination of correspondence and initial 3D localization among neuroelectrode detections in the two projection images; and (3) deformable 3D-2D registration of neuroelectrodes according to a physical device model. The method was evaluated in phantom, cadaver, and clinical studies in terms of (a) the accuracy of neuroelectrode registration and (b) the quality of metal artifact reduction (MAR) in cone-beam CT (CBCT) in which the deformably registered neuroelectrode models are taken as input to the MAR.
Results:
The combined deep-learning and model-based deformable 3D-2D registration approach achieved 0.2±0.1 mm accuracy in cadaver studies and 0.6±0.3 mm accuracy in clinical studies. The detection network and 3D correspondence provided initialization of 3D-2D registration within 2 mm, which facilitated end-to-end registration runtime within 10 s. Metal artifacts, quantified as the standard deviation in voxel values in tissue adjacent to neuroelectrodes, were reduced by 72% in phantom studies and by 60% in first clinical studies.
Conclusions:
The method combines the speed and generalizability of deep learning (for initialization) with the precision and reliability of physical model-based registration to achieve accurate deformable 3D-2D registration and MAR in functional neurosurgery. Accurate 3D-2D guidance from fluoroscopy could overcome limitations associated with deformation in conventional navigation, and improved MAR could improve CBCT verification of neuroelectrode placement.
... A number of previous studies reported that frameless stereotactic brain biopsy has accuracy and complication rates comparable to frame-based stereotactic systems [1,2]. Furthermore, frameless techniques do not depend on burdensome stereotactic frames, have fewer limitations in space and handling during preoperative imaging, and allow easier planning, making it a time-and cost-saving procedure [5]. Nevertheless, it may provide less stability and accuracy during drilling and positioning, which ultimately might lead to the occurrence of a targeting error. ...
... Based on immediate postoperative MR images, the leads were placed an average of 0.84 ± 0.007 mm from the intended target, which is in line with previously published studies using the same technique. 16,22,33 These results compare favorably to those obtained with other techniques of DBS lead placement, 3,6,13,26,34 including the 39 leads placed using frame-based MER in the current study. These leads were located an average of 1.94 ± 0.21 mm (95% CI 1.54-2.34) ...
Objective:
Deep brain stimulation (DBS) lead placement is increasingly performed with the patient under general anesthesia by surgeons using intraoperative MRI (iMRI) guidance without microelectrode recording (MER) or macrostimulation. The authors assessed the accuracy of lead placement, safety, and motor outcomes in patients with Parkinson disease (PD) undergoing DBS lead placement into the globus pallidus internus (GPi) using iMRI or MER guidance.
Methods:
The authors identified all patients with PD who underwent either MER- or iMRI-guided GPi-DBS lead placement at Emory University between July 2007 and August 2016. Lead placement accuracy and adverse events were determined for all patients. Clinical outcomes were assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) part III motor scores for patients completing 12 months of follow-up. The authors also assessed the levodopa-equivalent daily dose (LEDD) and stimulation parameters.
Results:
Seventy-seven patients were identified (MER, n = 28; iMRI, n = 49), in whom 131 leads were placed. The stereotactic accuracy of the surgical procedure with respect to the planned lead location was 1.94 ± 0.21 mm (mean ± SEM) (95% CI 1.54-2.34) with frame-based MER and 0.84 ± 0.007 mm (95% CI 0.69-0.98) with iMRI. The rate of serious complications was similar, at 6.9% for MER-guided DBS lead placement and 9.4% for iMRI-guided DBS lead placement (RR 0.71 [95% CI 0.13%-3.9%]; p = 0.695). Fifty-seven patients were included in clinical outcome analyses (MER, n = 16; iMRI, n = 41). Both groups had similar characteristics at baseline, although patients undergoing MER-guided DBS had a lower response on their baseline levodopa challenge (44.8% ± 5.4% [95% CI 33.2%-56.4%] vs 61.6% ± 2.1% [95% CI 57.4%-65.8%]; t = 3.558, p = 0.001). Greater improvement was seen following iMRI-guided lead placement (43.2% ± 3.5% [95% CI 36.2%-50.3%]) versus MER-guided lead placement (25.5% ± 6.7% [95% CI 11.1%-39.8%]; F = 5.835, p = 0.019). When UPDRS III motor scores were assessed only in the contralateral hemibody (per-lead analyses), the improvements remained significantly different (37.1% ± 7.2% [95% CI 22.2%-51.9%] and 50.0% ± 3.5% [95% CI 43.1%-56.9%] for MER- and iMRI-guided DBS lead placement, respectively). Both groups exhibited similar reductions in LEDDs (21.2% and 20.9%, respectively; F = 0.221, p = 0.640). The locations of all active contacts and the 2D radial distance from these to consensus coordinates for GPi-DBS lead placement (x, ±20; y, +2; and z, -4) did not differ statistically by type of surgery.
Conclusions:
iMRI-guided GPi-DBS lead placement in PD patients was associated with significant improvement in clinical outcomes, comparable to those observed following MER-guided DBS lead placement. Furthermore, iMRI-guided DBS implantation produced a similar safety profile to that of the MER-guided procedure. As such, iMRI guidance is an alternative to MER guidance for patients undergoing GPi-DBS implantation for PD.
... This presents a serious disadvantage when compared to other frameless systems that do not require rigid head fixation. 4 Stereotactic accuracy depends as much on operative technique, registration process, and imaging accuracy as it does on the actual system used. 5 This is corroborated by the present study, which showed a decrease in accuracy when going from the rigid cannula stylet to the flexible DBS lead. ...
... The accuracy of this method compares favorably to other techniques of DBS electrode placement. 4,7,10,11,24,26,28 In GPi-DBS, the efficacy of stimulation depends on the precise placement of the electrode within the posteroventral (motor) portion of this structure, albeit with sufficient distance from the lateral border of the internal capsule to limit undesired motor side effects. 9 In our experience, suboptimal outcomes, both in the degree of improvement in dystonic symptoms and in low side-effect thresholds, warrant a review in our multidisciplinary surgical conference, where lead location is assessed as one of several factors. ...
OBJECTIVE
Lead placement for deep brain stimulation (DBS) using intraoperative MRI (iMRI) relies solely on real-time intraoperative neuroimaging to guide electrode placement, without microelectrode recording (MER) or electrical stimulation. There is limited information, however, on outcomes after iMRI-guided DBS for dystonia. The authors evaluated clinical outcomes and targeting accuracy in patients with dystonia who underwent lead placement using an iMRI targeting platform.
METHODS
Patients with dystonia undergoing iMRI-guided lead placement in the globus pallidus pars internus (GPi) were identified. Patients with a prior ablative or MER-guided procedure were excluded from clinical outcomes analysis. Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) scores and Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores were assessed preoperatively and at 6 and 12 months postoperatively. Other measures analyzed include lead accuracy, complications/adverse events, and stimulation parameters.
RESULTS
A total of 60 leads were implanted in 30 patients. Stereotactic lead accuracy in the axial plane was 0.93 ± 0.12 mm from the intended target. Nineteen patients (idiopathic focal, n = 7; idiopathic segmental, n = 5; DYT1, n = 1; tardive, n = 2; other secondary, n = 4) were included in clinical outcomes analysis. The mean improvement in BFMDRS score was 51.9% ± 9.7% at 6 months and 63.4% ± 8.0% at 1 year. TWSTRS scores in patients with predominant cervical dystonia (n = 13) improved by 53.3% ± 10.5% at 6 months and 67.6% ± 9.0% at 1 year. Serious complications occurred in 6 patients (20%), involving 8 of 60 implanted leads (13.3%). The rate of serious complications across all patients undergoing iMRI-guided DBS at the authors’ institution was further reviewed, including an additional 53 patients undergoing GPi-DBS for Parkinson disease. In this expanded cohort, serious complications occurred in 11 patients (13.3%) involving 15 leads (10.1%).
CONCLUSIONS
Intraoperative MRI–guided lead placement in patients with dystonia showed improvement in clinical outcomes comparable to previously reported results using awake MER-guided lead placement. The accuracy of lead placement was high, and the procedure was well tolerated in the majority of patients. However, a number of patients experienced serious adverse events that were attributable to the introduction of a novel technique into a busy neurosurgical practice, and which led to the revision of protocols, product inserts, and on-site training.
