Improving Safety of MRI in Patients with Deep Brain Stimulation Devices.
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ABSTRACT:
SUBMITTER: Boutet A
PROVIDER: S-EPMC7543718 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDeep brain stimulation (DBS) is an established treatment for patients with movement disorders. Patients receiving chronic DBS provide a unique opportunity to explore the underlying mechanisms of DBS using functional MRI. It has been shown that the main safety concern with MRI in these patients is heating at the electrode tips - which can be minimised with strict adherence to a supervised acquisition protocol using a head-transmit/receive coil at 1.5T. MRI using the body-transmit coil with a multi-channel receive head coil has a number of potential advantages including an improved signal-to-noise ratio.Study outlineWe compared the safety of cranial MRI in an in vitro model of bilateral DBS using both head-transmit and body-transmit coils. We performed fibre-optic thermometry at a Medtronic ActivaPC device and Medtronic 3389 electrodes during turbo-spin echo (TSE) MRI using both coil arrangements at 1.5T and 3T, in addition to gradient-echo echo-planar fMRI exposure at 1.5T. Finally, we investigated the effect of transmit-coil choice on DBS stimulus delivery during MRI.ResultsTemperature increases were consistently largest at the electrode tips. Changing from head- to body-transmit coil significantly increased the electrode temperature elevation during TSE scans with scanner-reported head SAR 0.2W/kg from 0.45°C to 0.79°C (p<0.001) at 1.5T, and from 1.25°C to 1.44°C (p<0.001) at 3T. The position of the phantom relative to the body coil significantly impacted on electrode heating at 1.5T; however, the greatest heating observed in any position tested remained <1°C at this field strength.ConclusionsWe conclude that (1) with our specific hardware and SAR-limited protocol, body-transmit cranial MRI at 1.5T does not produce heating exceeding international guidelines, even in cases of poorly positioned patients, (2) cranial MRI at 3T can readily produce heating exceeding international guidelines, (3) patients with ActivaPC Medtronic systems are safe to be recruited to future fMRI experiments performed under the specific conditions defined by our protocol, with no likelihood of confound by inappropriate stimulus delivery.
| S-EPMC4465697 | biostudies-literature
Project description:Millions of patients around the world are affected by neurological and psychiatric disorders. Deep brain stimulation (DBS) is a device-based therapy that could have fewer side-effects and higher efficiencies in drug-resistant patients compared to other therapeutic options such as pharmacological approaches. Thus far, several efforts have been made to incorporate a feedback loop into DBS devices to make them operate in a closed-loop manner.This paper presents a comprehensive investigation into the existing research-based and commercial closed-loop DBS devices. It describes a brief history of closed-loop DBS techniques, biomarkers and algorithms used for closing the feedback loop, components of the current research-based and commercial closed-loop DBS devices, and advancements and challenges in this field of research. This review also includes a comparison of the closed-loop DBS devices and provides the future directions of this area of research.Although we are in the early stages of the closed-loop DBS approach, there have been fruitful efforts in design and development of closed-loop DBS devices. To date, only one commercial closed-loop DBS device has been manufactured. However, this system does not have an intelligent and patient dependent control algorithm. A closed-loop DBS device requires a control algorithm to learn and optimize the stimulation parameters according to the brain clinical state.The promising clinical effects of open-loop DBS have been demonstrated, indicating DBS as a pioneer technology and treatment option to serve neurological patients. However, like other commercial devices, DBS needs to be automated and modernized.
| S-EPMC5553781 | biostudies-other
Project description:Deep Brain Stimulation (DBS) is a promising treatment for neurological and psychiatric disorders. The mechanism of action and the effects of electrical fields administered to the brain by means of an electrode remain to be elucidated. The effects of DBS have been investigated primarily by electrophysiological and neurochemical studies, which lack the ability to investigate DBS-related responses on a whole-brain scale. Visualization of whole-brain effects of DBS requires functional imaging techniques such as functional Magnetic Resonance Imaging (fMRI), which reflects changes in blood oxygen level dependent (BOLD) responses throughout the entire brain volume. In order to visualize BOLD responses induced by DBS, we have developed an MRI-compatible electrode and an acquisition protocol to perform DBS during BOLD fMRI. In this study, we investigate whether DBS during fMRI is valuable to study local and whole-brain effects of hippocampal DBS and to investigate the changes induced by different stimulation intensities. Seven rats were stereotactically implanted with a custom-made MRI-compatible DBS-electrode in the right hippocampus. High frequency Poisson distributed stimulation was applied using a block-design paradigm. Data were processed by means of Independent Component Analysis. Clusters were considered significant when p-values were <0.05 after correction for multiple comparisons. Our data indicate that real-time hippocampal DBS evokes a bilateral BOLD response in hippocampal and other mesolimbic structures, depending on the applied stimulation intensity. We conclude that simultaneous DBS and fMRI can be used to detect local and whole-brain responses to circuit activation with different stimulation intensities, making this technique potentially powerful for exploration of cerebral changes in response to DBS for both preclinical and clinical DBS.
| S-EPMC4508110 | biostudies-literature
Project description:PurposeTo assess the mean and variance performance of parallel transmission (pTx) coils for reduction of the absorbed power around electrodes (APAE) in patients implanted with deep brain stimulation (DBS) devices.MethodsWe simulated 4 pTx coils (8 and 16 channels, head and body coils) and a birdcage body coil. We characterized the RF safety risk using the APAE, which is the integral of the deposited power (in Watts) in a small cylindrical volume of brain tissue surrounding the electrode tips. We assessed the APAE mean and variance by simulation of 5 realistic DBS patient models that include the full DBS implant length, extracranial loops, and implanted pulse generator.ResultsPTx coils with 8 (16) channels were able to reduce the APAE by >18× (>169×) compared to the birdcage coil in average for all patient models, at no cost in term of flip angle uniformity or global specific absorption rate (SAR). Moreover, local pTx coils performed significantly better than body arrays.ConclusionPTx is a possible solution to the problem of RF heating of DBS patients when performing MRI, but the large interpatient variability of the APAE indicates that patient-specific safety monitoring may be needed.
| S-EPMC6778698 | biostudies-literature
Project description:BackgroundChronic pain occurs in 83% of Parkinson disease (PD) patients and deep brain stimulation (DBS) has shown to result in pain relief in a subset of patients, though the mechanism is unclear.ObjectiveTo compare functional magnetic resonance imaging (MRI) data in PD patients with chronic pain without DBS, those whose pain was relieved (PR) with DBS and those whose pain was not relieved (PNR) with DBS.MethodsFunctional MRI (fMRI) with blood oxygen level-dependent activation data was obtained in 15 patients in control, PR, and PNR patients. fMRI was obtained in the presence and absence of a mechanical stimuli with DBS ON and DBS OFF. Voxel-wise analysis using pain OFF data was used to determine which regions were altered during pain ON periods.ResultsAt the time of MRI, pain was scored a 5.4 ± 1.2 out of 10 in the control, 4.25 ± 1.18 in PNR, and 0.8 ± 0.67 in PR cohorts. Group analysis of control and PNR groups showed primary somatosensory (SI) deactivation, whereas PR patients showed thalamic deactivation and SI activation. DBS resulted in more decreased activity in PR than PNR (P < .05) and more activity in anterior cingulate cortex (ACC) in PNR patients (P < .05).ConclusionPatients in the control and PNR groups showed SI deactivation at baseline in contrast to the PR patients who showed SI activation. With DBS ON, the PR cohort had less activity in SI, whereas the PNR had more anterior cingulate cortex activity. We provide pilot data that patients whose pain responds to DBS may have a different fMRI signature than those who do not, and PR and PNR cohorts produced different brain responses when DBS is employed.
| S-EPMC6855980 | biostudies-literature
Project description:PurposeThe purpose of this study is to present a strategy to calculate the implant-friendly (IF) excitation modes-which mitigate the RF heating at the contacts of deep brain stimulation (DBS) electrodes-of multichannel RF coils at 7 T.MethodsAn induced RF current on an implantable electrode generates a scattered magnetic field whose left-handed circularly polarizing component ( B1+$$ B{1}^{+} $$ ) is approximated using a B1+$$ B{1}^{+} $$ -mapping technique and subsequently used as a gauge for the electrode's induced current. Using this approach, the relative induced currents resulting from each channel of a multichannel RF coil on the DBS electrode were calculated. The IF modes of the corresponding multichannel coil were determined by calculating the null space of the relative induced currents. The proposed strategy was tested and validated for unilateral and bilateral commercial DBS electrodes (directional lead; Infinity DBS system, Abbott Laboratories) placed inside a uniform phantom by performing heating and imaging studies on a 7T MRI scanner using a 16-channel transceive RF coil.ResultsNeither individual IF modes nor shim solutions obtained from IF modes induced significant temperature increase when used for a high-power turbo spin-echo sequence. In contrast, shimming with the scanner's toolbox (i.e., based on per-channel B1+$$ B{1}^{+} $$ fields) resulted in a more than 2°C temperature increase for the same amount of input power.ConclusionA strategy for calculating the IF modes of a multichannel RF coil is presented. This strategy was validated using a 16-channel RF coil at 7 T for unilateral and bilateral commercial DBS electrodes inside a uniform phantom.
| S-EPMC10543551 | biostudies-literature
Project description:PurposeTo explore the safety and clinical utility of MRI in participants with non-MRI-conditional cardiac implantable electronic devices, by establishing the Patient Registry of Magnetic Resonance Imaging in Non-Approved DEvices (PROMeNADe).Materials and methodsFrom September 2015 to June 2019, 532 participants (211 women) with a mean age of 69 years ± 14 (standard deviation) were enrolled prospectively in the PROMeNADe registry (ClinicalTrials.gov identifier: NCT03081364) and underwent a total of 608 MRI examinations (61 cardiac MRI examinations). All participants had device interrogations performed before and after each MRI. Pacemaker-dependent patients received asynchronous pacing. Patients with an implantable cardioverter defibrillator (ICD) had tachycardia therapies disabled during the MRI. An electrophysiology nurse monitored participants for any hemodynamic or rhythm abnormalities. Referring physicians were surveyed regarding the clinical utility of the MRI. Standard descriptive analyses included summary statistics with percentages and means.ResultsCardiac devices included pacemakers (46%), ICDs (30%), cardiac resynchronization therapy (CRT) pacemakers (4%), and CRT defibrillators (17%), as well as abandoned leads (2%). Pacemaker-dependent patients comprised 27% of all MRI examinations. There were no patient- or device-related complications. Clinical utility surveys of MRI examinations were completed by 150 physicians. According to the survey responses, these MRI examinations changed the suspected diagnosis 25% of the time and changed suspected prognosis in 26% of participants, with planned medical or surgical treatment being changed 42% of the time.ConclusionThis registry demonstrates that MRI examinations, including thoracic MRI examinations, can be performed safely in patients who have non-MRI-conditional devices, in pacemaker-dependent patients with ICDs, and in patients with abandoned leads. These MRI examinations can have a substantial impact on patient care, justifying the extensive resources used to perform them.Supplemental material is available for this article.© RSNA, 2020See also the commentary by Peshock in this issue.
| S-EPMC7977944 | biostudies-literature
Project description:ObjectivesThe paucity of safety information on intrauterine devices (IUD) for magnetic resonance imaging (MRI) examinations is clinically relevant. The aim of this study is to evaluate the MRI safety of clinically used IUDs composed of copper/gold and stainless steel at 1.5T and 3.0T.Materials and methodsWe assessed and compared the displacement force, torque effects, presence of imaging artifacts and heating of IUDs composed of copper/gold (western IUDs) and stainless steel (China) on 1.5 and 3.0T MRI systems.ResultsGold/Copper IUDs can show small deflection angles of 7° ± 7° in the worst-case field gradient of 40T/m (equivalent to magnetic force of 0.5 mN), while the stainless steel IUD experienced significant magnetic force and deflection (Force > 7.5 N; deflection angle 90° ± 1°). Manual rotation and suspension method show no torque effects on gold/copper IUDs but high torque effects were observed by manual rotation on the stainless steel IUD. Heating measurements showed a temperature increase (rescaled to a wbSAR of 4 W/kg) of 1.4°C at 1.5T / 3.4°C at 3.0 T (stainless steel IUD), 3.2°C at 1.5 T / 3.8°C at 3 T (copper/gold IUD), 3.3°C at 1.5 T / 4.8°C at 3 T (copper 1), 3.8°C at 1.5 T / 4.8°C at 3 T (copper 2). The visible imaging artifacts of the copper and gold IUDs at 3 T MRI reach a diameter of 4 mm ± 1 mm, while the stainless steel IUD resulted in artifacts measuring 200mm ± 10 mm when using gradient echo pulse sequences.ConclusionsStandard IUDs (copper/gold) can be considered as conditional for MR safety at 1.5 T and 3.0 T, demonstrating at wbSAR up to 4W/kg and a magnetic field gradient of up to 40T/m with minimal imaging artifacts. The stainless steel IUD, however, induces unacceptable artifacts and is potentially harmful to patients during MRI due to high magnetic dislocation forces and torque (MR unsafe).
| S-EPMC6177157 | biostudies-literature
Project description:BackgroundDeep brain stimulation (DBS) is an effective technique to treat patients with advanced Parkinson's disease. The surgical procedure of DBS implantation is generally performed under local anesthesia due to the need for intraoperative clinical testing. However, this procedure is long (5-7 h on average) and, therefore, the objective that the patient remains co-operative and tolerates the intervention well is a real challenge.ObjectiveTo evaluate the additional benefit of electroacupuncture (EA) performed intraoperatively to improve the comfort of parkinsonian patients during surgical DBS implantation.MethodsThis single-center randomized study compared two groups of patients. In the first group, DBS implantation was performed under local anesthesia alone, while the second group received EA in addition. The patients were evaluated preoperatively, during the different stages of the surgery, and 2 days after surgery, using the 9-item Edmonton Symptom Assessment System (ESAS), including a total sum score and physical and emotional subscores.ResultsThe data of nine patients were analyzed in each group. Although pain and tiredness increased in both groups after placement of the stereotactic frame, the ESAS item "lack of appetite", as well as the ESAS total score and physical subscore increased after completion of the first burr hole until the end of the surgical procedure in the control group only. ESAS total score and physical subscore were significantly higher at the end of the intervention in the control group compared to the EA group. After the surgical intervention (D2), anxiety and ESAS emotional subscore were improved in both groups, but the feeling of wellbeing improved in the EA group only. Finally, one patient developed delirium during the intervention and none in the EA group.DiscussionThis study shows that intraoperative electroacupuncture significantly improves the tolerance of DBS surgery in parkinsonian patients. This easy-to-perform procedure could be fruitfully added in clinical practice.
| S-EPMC9145270 | biostudies-literature
Project description:Objective.Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease (PD) but its success depends on a time-consuming process of trial-and-error to identify the optimal stimulation settings for each individual patient. Data-driven optimization algorithms have been proposed to efficiently find the stimulation setting that maximizes a quantitative biomarker of symptom relief. However, these algorithms cannot efficiently take into account stimulation settings that may control symptoms but also cause side effects. Here we demonstrate how multi-objective data-driven optimization can be used to find the optimal trade-off between maximizing symptom relief and minimizing side effects.Approach.Cortical and motor evoked potential data collected from PD patients during intraoperative stimulation of the subthalamic nucleus were used to construct a framework for designing and prototyping data-driven multi-objective optimization algorithms. Using this framework, we explored how these techniques can be applied clinically, and characterized the design features critical for solving this optimization problem. Our two optimization objectives were to maximize cortical evoked potentials, a putative biomarker of therapeutic benefit, and to minimize motor potentials, a biomarker of motor side effects.Main Results.Using thisin silicodesign framework, we demonstrated how the optimal trade-off between two objectives can substantially reduce the stimulation parameter space by 61 ± 19%. The best algorithm for identifying the optimal trade-off between the two objectives was a Bayesian optimization approach with an area under the receiver operating characteristic curve of up to 0.94 ± 0.02, which was possible with the use of a surrogate model and a well-tuned acquisition function to efficiently select which stimulation settings to sample.Significance.These findings show that multi-objective optimization is a promising approach for identifying the optimal trade-off between symptom relief and side effects in DBS. Moreover, these approaches can be readily extended to newly discovered biomarkers, adapted to DBS for disorders beyond PD, and can scale with the development of more complex DBS devices.
| S-EPMC9638882 | biostudies-literature