210 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if new educational program prior to epilepsy surgery can either decrease the risk of cognitive decline after surgery or be a help to those patients who experience a decline after undergoing epilepsy surgery. Participants will participate in 2 individual virtual sessions and 4 virtual group sessions over the course of 5-6 weeks prior to their epilepsy surgery. They will asked to fill out online surveys and questionnaires at various times throughout the study, up to 12 months after their surgery. To see if the educational program works, researchers will compare those participating in the educational program with those that are receiving the standard epilepsy care prior to surgery.
This early phase I trial tests the safety and reliability of an investigational imaging technique called quantitative oblique back illumination microscopy (qOBM) during brain surgery for detecting brain tumors and brain tumor margins in patients with glioblastoma, astrocytoma, or oligodendroglioma. Surgical margins refer to the edge or border of the tissue removed in cancer surgery. qOBM may be able to assess and reveal brain tumor surgical margins in a more safe and reliable manner.
Brain activity will be recorded while participants rest and/or perform perceptual discrimination tasks. These tasks include the presentation of sensory stimuli and require participants to detect and discriminate these stimuli, and to report about the objective properties of the stimuli as well as about their subjective perceptual experience using ratings of confidence, visibility, and/or alertness/sleepiness. All sensory stimuli used are neutral and consist of visual stimuli presented on a computer screen (either basic visual stimuli, e.g. an arrow, a grating or a dot, or neutral pictures of e.g. objects, buildings, landscapes), or auditory stimuli presented via headphones (either basic sounds, e.g. a beep or noise, or more complex sounds, e.g. a spoken word or rhythm). The experimental tasks may require participants to compare between sensory stimuli presented at different spatial locations or at different times, and/or to focus their attention on specific stimuli while suppressing distracting information; additionally, tasks may require participants to remember these stimuli for a delayed report. In these tasks, participants' performance will be quantified by motor responses (i.e., button press), reaction times and subjective ratings (confidence, visibility, alertness/sleepiness). Brain activity will be recorded by means of electroencephalography (EEG), a non-invasive technique consisting of electrodes placed along the scalp that record electrical field potentials generated by cortical neurons. EEG will be used to record brain activity prior to and in response to the sensory stimuli presented during the cognitive and perceptual tasks as well as during the participants' responses. Additionally, EEG may be used to record brain activity during a baseline resting state, while participants are not engaged in any particular tasks. In particular, the analysis of the EEG signal will focus on event-related brain activity (i.e., in response to the stimuli) such as event-related potentials (ERP), as well as ongoing and spontaneous and/or induced brain activity quantified as oscillations: wave-like signal fluctuations reflecting rhythmic variations of membrane potentials of cortical neurons. In addition, the investigators will use MRI to take an anatomical image of the brain to facilitate localizing the sources of the activity measured with EEG.
The purpose of this study is to utilize a sensor incorporated into a brain retractor blade to monitor electrical activity and pressure applied to the brain during retraction required for the selected skull base operations. The overall goal of the study is to develop a protocol and guidelines to prevent the development of brain retraction injury during neurosurgical procedures requiring significant retraction.
This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned. The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery. Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.
The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks. For some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.
Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression.
The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are: * Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery? * Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision? Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid. Participants will: * Receive the decision aid at the beginning of the evaluation process or towards the end * Complete surveys at 5 visits (remote or in-person) over approximately 6 months
This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.
Researchers want to test a procedure called deep brain simulation (DBS) to treat focal hand dystonia (FHD). A device called a neurostimulator is placed in the chest. It is attached to wires placed in brain areas that affect movement. Stimulating these areas can help block nerve signals that cause abnormal movements. Objectives: To test DBS as treatment for FHD. To learn about brain and nerve cell function in people with dystonia. Eligibility: People ages 18 and older with severe FHD who have tried botulinum toxin treatment at least twice Design: Participation lasts 5 years. Participants will be screened with: Medical history Physical exam Videotape of their dystonia Blood, urine, and heart tests Brain MRI scan Chest X-ray Neuropsychological tests: answering questions, doing simple actions, and taking memory and thinking tests. Hand movement tests Participants will have surgery: A frame fixes their head to the operating table. A small hole is made in the skull. Wires are inserted to record brain activity and stimulate the brain while they do simple tasks. The wires are removed and the DBS electrode is inserted into the hole. The neurostimulator is placed under the skin of the chest, with wires running to the electrode in the brain. They will have CT and MRI scans during surgery. Participants will recover in the hospital for about 1 week. The neurostimulator will be turned on 1 4 weeks after discharge. Participants will have regular visits until the study ends. Visits include: Checking symptoms and side effects MRI Movement, thinking, and memory tests If the neurostimulator s battery runs out, participants will have surgery to replace it.
The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS) surgery in patients who are deeply sedated, "asleep," or not sedated, "awake," during surgical implantation of the DBS electrode. The investigators hypothesize that the clinical outcome, neurophysiological findings, and surgical accuracy will be equivalent. There are 3 specific aims: 1) compare the activity of the neurons in the patients' brain in the asleep and awake groups using microelectrode recording, to see how this affects clinical outcome capability of microelectrode recordings and macrostimulation to identify the subthalamic nucleus in asleep patients. 2) Determine if intraoperative CT scans of the DBS electrode is sufficient for accurate DBS electrode placement. 3) Compare the clinical outcome on their Parkinson's disease between awake and asleep DBS patients.
The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.
Background: - Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery. Objectives: * To study how DBS surgery affects Parkinson s disease, dystonia, and tremor. * To obtain information on brain and nerve cell function during DBS surgery. Eligibility: - People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia. Design: * Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests. * During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier. * After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings. * Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).
Objective: This study aimed to integrate findings from spinal and cranial surgeries with existing literature, emphasizing the role of Intraoperative Neurophysiological Monitoring (IONM) in improving surgical outcomes through best practices. Methodology: Multimodal IONM, including motor evoked potential (MEP), somatosensory evoked potential (SSEP), and electromyography (EMG), was utilized in surgeries at Duke University Hospitals. Challenges included a small sample size and limited access to medical records. Findings: Effectiveness of IONM: High sensitivity (97.73%), specificity (83.33%), and predictive value of multimodal IONM confirmed its role in detecting intraoperative neurological injuries and optimizing outcomes. Demographics: Analysis of 50 cases (58% male, aged 13-67 years) revealed demographic influences on surgical challenges and outcomes. IONM Alerts: A 50% reduction in MEP/SSEP amplitudes was a critical criterion, with reversible alerts accounting for 70%, emphasizing the dynamic nature of neural responses. Alert Causes \& Management: Excessive dissection was a common cause of alerts. Interventions like warm saline irrigation and surgical pauses mitigated risks. Outcome Associations: Most patients (88%) experienced no new postoperative deficits, with significant associations between alert reversibility and deficit occurrence. Statistical Insights: Predictive Value: Strong correlations were observed between alert patterns and postoperative outcomes, with SSEP/MEP alerts reliably predicting neurological deficits. Technology \& Resources: Modern devices, updated technology, and skilled staff were critical for high-quality results, highlighting the adage that "poor monitoring is worse than no monitoring." Contextual Observations: Heterogeneity of Cases: Diagnoses ranged from cervical intramedullary tumors to lumbar canal stenosis, requiring tailored interventions. EMG Utility: EMG showed stability with fewer alerts, proving beneficial in specific surgeries. Corrective Measures: Adjustments in mean arterial blood pressure and steroid use showcased adaptive intraoperative strategies. Protocol Gaps: The absence of standardized IONM alert response protocols was noted, underscoring the need for future research.
Study of Regional Cerebral Oxygenation and Brain Blood Volume changes during Cardiac Surgery using the NeurOS system
This research study is studying a drug called Demeclocycline that may help brain surgeons see tumors with a microscope during surgery.
Deep brain stimulation (DBS) is an FDA approved, and widely used method for treating the motor symptoms of Parkinson's disease (PD), Essential Tremor (ET), Dystonia and Obsessive Compulsive disorder (OCD). Over 100,000 patients worldwide have now been implanted with DBS devices. Current approved methods to locate the DBS target regions in the brain use a combination of stereotactic imaging techniques and measurements of the electrical activity of brain cells. As part of the standard clinical technique, electrical data are collected from individual nerve cells. The target brain region emits unique electrical signals. At certain brain locations, during DBS surgery, additional electrical data that are generated in response to sound will be collected. Regions of the brain that have a decreased response to repeated sound (auditory gating) may be important DBS targets for improving thinking. The aims are (i) during DBS surgery, in addition to EEG, use microelectrodes in the brain to find brain regions, along the normal path to the DBS target, where auditory gating occurs and then (ii) determine if stimulation of the identified region(s) alters auditory gating measured by EEG. Also an additional aim (iii) is to measure electrical activity at the scalp with EEG to characterize auditory gating in patients before and after DBS surgery and also a healthy control population.
There is a growing trend in functional neurosurgery toward direct anatomical targeting for deep brain stimulation (DBS). This study describes a method and reports the initial experience placing DBS electrodes under general anesthesia without the use of microelectrode recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.
Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life. New strategies of care are needed to avoid rising complications for the growing number of aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing brain injury during surgery from inadequate brain blood flow using techniques that could be widely employed.
The goal of this observational study is to record and analyze factors putatively affecting the clinical outcomes among patients undergoing transcranial magnetic stimulation (TMS) treatment for major depressive disorder (MDD) or generalized anxiety disorder (GAD). The main questions it aims to answer are: 1. Which factors have the greatest causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)? 2. Which factors have a minimal causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)? Participants already undergoing TMS as part of their treatment plan for MDD/GAD answer survey questions about their symptoms before, during, and up to 1 year post-treatment. Factors affecting clinical outcomes such as stimulation parameters, behavioral factors, physiological factors, patient characteristics, and pharmacological factors, are also recorded.
This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy. Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation. Patients will be followed in the outpatient setting for up to a year after therapy application. Surgical, clinical, and radiographic data will be obtained during these visits
The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.
This pilot research trial studies blood brain barrier differences in patients with brain tumors undergoing surgery. Studying samples of tissue and blood from patients with brain tumors in the laboratory may help doctors to understand how well drugs get into different parts of a brain tumor. This may help them to determine which types of drugs may be best for treating brain tumors.
This pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. Using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.
This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.
A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.
It is extremely important to identify and distinguish healthy brain tissue from diseased brain tissue during neurosurgery. If normal tissue is damaged during neurosurgery it can result in long term neurological problems for the patient. The brain tissue as it appears prior to the operation on CT scan and MRI is occasionally very different from how it appears during the actual operation. Therefore, it is necessary to develop diagnostic procedures that can be used during the operation Presently, the techniques used for intraoperative mapping of the brain are not reliable in all cases in which they are used. Researchers in this study have developed a new approach that may allow diseased brain tissue to be located during an operation with little risk. This new approach uses nfrared technology to locate the diseased tissue and identify healthy brain tissue. The goal of this study is to investigate the clinical use of intraoperative infrared (IR) neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue during the operation.
The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological diseases, like Parkinson's disease, cause abnormalities in the brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases. Through this research, the investigators will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks. This study aims to enroll up to 75 subjects over a period of 2.5 years. Those who participate in the study will spend up to 40 minutes during their deep brain stimulation surgery during which researchers will record signals from deep structures within the brain as well as the surface of the brain using electrodes that are temporarily placed for research purposes. During the study, researchers will record signals while subjects perform three different tasks, in some cases while the brain is stimulated. Study participation is limited to the intraoperative environment with no additional study visits required.
Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.