
Search Results Within Category "Brain & Nervous System"
Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics
This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.
• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.
• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)
This study will compare the effects of apixaban to aspirin in patients who have atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.
• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
• contact study staff for additional exclusion criteria
Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)
This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.
• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord
The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.
• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) (teleABLE)
We are exploring ways to increase physical activity after stroke using a web-based rehabilitation program. The purpose of this study is to adapt the Activating Behavior for Lasting Engagement (ABLE) program using video visits so people with stroke can participate from home.
• experienced a stroke in the last 12 months
• currently spend at least 6 hours per day sitting
• access to a device for virtual video visits
EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A National Comparison Study
This is a study enrolling patients receiving care for early psychosis across the United States. Participants will be randomly assigned to one of two groups. The first group will use two mobile apps, computerized brain training and a motivational smart phone app, for a period of 12 weeks. The other group will participate in their regular clinical care. There will be 4 study timepoints: intake, post-training, 6-month follow up, and 12-month follow up. There is also an optional interview about experiences of loneliness.
• aged 15-40 inclusive
• enrolled in an early psychosis coordinated specialty care clinic (PI will determine this)
• in good physical health & stable psychiatric status
• fluent in spoken and written English
• have access to a smart phone (or other mobile device) and computer or tablet
• participated in significant cognitive training programs within the last three years
• neurological disorder that may interfere with participation
• substance abuse disorder that would interfere with participation
• risk of suicidal behavior
Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders
We are studying brain mechanisms related to chronic temporomandibular disorder (TMD) pain. We are looking at brain structural and functional characteristics that can potentially explain why some people experience persistent pain in their jaws for months or years. We will compare this to information we get from people who do not experience TMD pain. We expect that this new knowledge will improve our understanding of this chronic pain condition and help us develop better treatments.
• Female participants only (biological sex)
• Age between 18-65 years
• Pain-free participants OR
• Chronic jaw pain ( > 3 months)
• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only
Plasticity of motor systems in early stage Parkinson's disease
The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Asymmetries in motor control and their impact on functional independence
We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.
• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Wearable monitor for FOG detection
Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.
• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson’s disease, or a family member with a diagnosis of Parkinson’s disease.
Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.
• any gender identity
• 11-17 years old
• past suicide attempt and/or current suicide ideation
• Autism Spectrum Disorder
• Cognitive Developmental Delay (IQ < 75 i.e.intellectual disability)
• diagnosis of Schizophrenia
Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients
Balance and walking problems in patients with Parkinson’s Disease do not respond well to the typical medication or surgical treatments. This research study uses five small wearable devices that attach to clothing and can measure the body’s location while performing walking tests, balance tests, and normal daily activities. By comparing patients with Parkinson’s Disease to people of similar age without Parkinson’s Disease, we hope to learn important differences relevant to the walking and balance problems in Parkinson’s Disease
• Anyone who has been diagnosed with parkinsonism including Parkinsons disease, Normal Pressure Hydrocephalus, or atypical parkinsonism
• Healthy adults of similar age as study participants
• people who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)
The purpose of the study is to see how aerobic exercise and cognitive training alone or together affect cognition, brain structure and function, and physical fitness over the course of 18 months.
• diagnosis of Mild Cognitive Impairment
• live in the community
• English speaking
• adequate vision
• physician confirms that exercise is safe
• stable on drugs affecting cognitive and psychological status
• able to have a MRI
• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury
Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.
• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Prospective quantitative kinematic assessment of patients with normal pressure hydrocephalus
The purpose of this research is to better understand balance and walking in patients with normal pressure hydrocephalus. Balance and walking problems in patients with normal pressure hydrocephalus do not respond well to the typical medication treatments. This research study uses small wearable devices that attach to your clothing and can measure your body’s location while performing walking and balance tests.
• People who have dementia of sufficient severity to impair their ability to make health-care decisions
• People who have other types of Parkinson's Disease
• People who are unable to stand without help
Vestibular and Cortical Contributions to Transitions in Freezing of Gait and Parkinson's Disease
This study will examine the brain activation associated with the transition between movements in Parkinson’s disease, and if these changes are related to the development of problems with moving (like freezing of gait) and thinking. We will look at brain activity associated with the vestibular (inner ear) and cortical (surface of the brain) systems. People with Parkinson’s disease (especially people with freezing of gait) sometimes have difficulty initiating changes in movement types, such as going from standing to walking, turning, or switching between slow and fast repetitive movements. The difficulty in movement transitions may be associated with an overactive vestibular system (inner ear) or cortical system. In each experiment in this study, we expect about 20-25 participants with Parkinson’s disease and freezing of gait, 20-25 participants with Parkinson’s without freezing of gait, and 20-25 control participants
• age 21-80 years
• diagnosis of idiopathic PD with and without freezing gait
• able to walk independently without the use of an assistive device (e.g. cane) for 50 meters (about 160 feet)
• for HEALTHY OLDER ADULTS: 40-80 years old, able to walk independently without a cane or walker and able to perform complex activities of daily living independently
• for HEALTHY YOUNG ADULTS: 21-44 years and able to walk independently without a cane or walker
• any musculoskeletal disorder that affects the ability to stand or walk
• history of musculoskeletal disorders that significantly affect movement of lower limbs
• uncorrected visual impairment
• history of visual and/or vestibular conditions
• moderate to severe hearing impairment
• women who are pregnant
• study staff will discuss additional exclusion criteria
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
Neural Correlates of Goal Prioritization and Conscientiousness
This research will use neuroimaging to study the brain systems involved in prioritizing goals effectively, as well as testing whether variation in those systems is associated with the personality trait conscientiousness, which reflects organization, self-discipline, and industriousness and predicts important health and other life outcomes.
• age 20 - 50
• right handed
• no major psychiatric illness
• claustrophobia
• any metal or devices in the body (e.g., pace makers, aneurysm clips etc.)
Bladder Management Patient Reported Outcomes for Young Adults with Spina Bifida
The purpose of this study is to determine how different bladder management methods affect the quality of life for young people with spina bifida. We hope to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with spina bifida.
• at least 14 years old
• diagnosis of spina bifida
• able to effectively communicate in English
• reconstructive surgery or urinary diversion in the last 3 months
• admitted to the hospital admission in the last month
Coordinated Reset Deep Brain Stimulation for Essential Tremor
This study is for people who have essential tremor and will be receiving the Boston Scientific Vercise Genus deep brain stimulation (DBS) system. We are studying the possibility that a kind of deep brain stimulation called "coordinated reset" stimulation (CR-DBS) will be more effective than current DBS treatment for essential tremor. We expect that participants will be in this research study for about 9 to 11 months.
• diagnosis of Essential Tremor (ET)
• age 21 or older
• will receive a Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
• history of musculoskeletal disorders that affect movement of the limbs or gait
• history of dementia or cognitive impairment
• significant psychiatric disease
• on medication that could cause tremor
• women who are pregnant
• prior brain surgery
Computational Modeling of Tic Change Trajectories in Tourette Syndrome
We are looking for participants who have tics. We would like to measure your tics before, during and after a course of Comprehensive Behavioral Intervention for Tics (CBIT) .
• age 12-17
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months
• at least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only)
• full scale IQ greater than 80
• previous diagnosis of psychosis or cognitive disability
• substance abuse or dependence within the past year
• neuroleptic/antipsychotic medications
Brain Training for Substance Use Disorders
Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.
• 18 to 65 years of age
• admitted to Fairview's Lodging Plus program for chemical dependency treatment with opioid use being the primary reason
• able to read at a minimum of a 6th grade reading level
• willing to provide own contact information for follow-up visit(s)
• for HEALTHY CONTROLS: 18 to 65 years old, able to read at a minimum of a 6th grade reading level, and willing to provide own contact information for follow-up visit(s)
• pregnancy
• history of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures)
• unable to see text and photos clearly on a computer display
• current or previous problems using opioids, other prescription (prescribed or not prescribed) or illicit drugs
• regular nicotine user (e.g., cigarette smoker, e-cig user) within the past 12 months and
• unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary
Brain Health Registry and Biospecimen Repository
The Brain Health Registry and Biospecimen Repository will create a research framework aiming to help us understand the causes of memory loss in Alzheimer's disease and other neurodegenerative disorders. We would like to recruit research participants 45+ years and up without any memory complaints, participants subjectively reporting memory complaints, and participants suffering from mild cognitive impairment or dementia symptoms due to neurodegenerative diseases. We will ask study participants about their medical history, their demographics, their social determinants of health, do a sleep quality assessment, and do neuropsychometric assessments. We will also create a biospecimen repository of blood, tissue and cerebral spinal fluid samples from the above participants.
Biorepository to Support ALS Research in Minnesota
The purpose of the study is to establish and maintain a biorepository of tissue and biospecimen samples relevant to Amyotrophic Lateral Sclerosis (ALS) research. We will obtain, store, and catalogue peripheral blood mononuclear cells (PBMCs), blood and blood components, skin punch biopsy samples, and cerebral spinal fluid (CSF) from people living with ALS, linked to clinical datasets, to advance ALS research.
• people living with ALS: people with a confirmed diagnosis of ALS
• Controls: people who have a neurological disorder other than ALS for which a comparison will assist in medical discovery Healthy controls: Individuals without ALS or other neurological disorders
• age less than 18 or greater than 90
A Window of Opportunity Trial of Mirdametinib plus Vorinostat for NF1 Associated, Malignant Peripheral Nerve Sheath Tumor; MPNST (Le-Na)
This is a small, Phase 0, window of opportunity study to provide human experience to support our pre-clinical data and gain preliminary information regarding the safety and tolerability of mirdametinib and vorinostat when given in combination.
• Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria
• Diagnosis of suspected MPNST by PET or MRI imaging
• Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
• Twelve years of age or older - Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1st dose of study drug
• Must be able to swallow capsules
• Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib
• Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat
• Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment
• Pregnant or breastfeeding – females of childbearing potential must have a negative pregnancy test (serum and urine) within 7 days prior to the 1st dose of the study drugs
• Significant cardiac disease
• Ophthalmologic conditions
• Radiation therapy or chemotherapy in the past year
• Participants receiving systemic or ocular glucocorticoid therapy within 14 days prior to the first dose of study treatment
A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.
The purpose of this research study is to compare surgical tumor removal followed by stereotactic radiotherapy (SRT) to surgical tumor removal followed by radiation therapy delivered by surgically implanted GammaTilesTM (GT). A GammaTile (GT) is an FDA cleared device used to provide radiation therapy following the removal of a brain tumor. GT are small (2cm x 2cm x 0.4cm) collagen squares/tiles that contain sources of radiation that look like grains of rice. If assigned to the GT study group, the doctor will place tiles containing the radiation sources in the cavity left after surgically removing the brain tumor. They do not need to be removed as the collagen tiles will be absorbed and the radiation sources can be left in place. If assigned to the SRT study group, SRT will take place 3-4 weeks after surgery and uses external beams to deliver radiation to the cavity left after surgically removing the brain tumor.
• one to four newly diagnosed brain metastases, from an extracranial primary tumor (found on MRI)
• planned surgery to remove one lesion is between 2.5 cm and 5.0 cm in size, other lesions must be less than 4.0 cm in size
• able to complete an MRI of the head with contrast
• fluent in English or Spanish language
• additional criteria apply, contact study staff
• past radiation or surgical therapy newly diagnosed lesion(s)
• more than 4 newly diagnosed metastases on MRI
• psychiatric, neurologic disease, injury impacting cognition
Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation
This study is comparing the benefits and adverse effects of two delivery methods to help patients relax and decrease anxiety during his/her time on mechanical ventilation. This study is not examining the medication but rather the process of how the patient receives the sedation medication: patient controlled or usual care.
• receiving mechanical ventilation (ventilator) in the Intensive Care Unit
• receiving medication for sedation or pain
• prone (facing down) ventilation being used
• low blood pressure that is being treated with medication
• unstable medical condition (staff will review)