Search Results
Satisfaction and usability assessment of a take-home device for tinnitus
This study is about assessing compliance, satisfaction, and usability of a take-home device for tinnitus management, specifically a bimodal neuromodulation device using customized acoustic stimulation paired with electrical ear stimulation. This study also examines whether integrative health (IH) practices – such as deep breathing – paired with bimodal neuromodulation can enhance long-term plasticity of the brain and reduce stress.
• Subjective tinnitus (only you can hear your tinnitus)
• tinnitus has a dominant pitch
• willing to commit to a 18-week study
• Objective tinnitus (other people can hear your tinnitus too)
• users of hearing aids or cochlear implants, or an electro-active implanted device
Closed Loop and Education for hypoglycemia Awareness Restoration (CLEAR) (CLEAR)
The purpose of this study is to learn how to improve hypoglycemia unawareness - a condition where people with Type 1 Diabetes may not be able to tell how low their blood sugar levels are. This study will use different types of education and devices to see if they can help people become more aware when the blood sugar is low.
• 18 to 75 years old
• diagnosis of type 1 diabetes
• sometimes struggle to feel symptoms of low blood sugar
• have had diabetes for at least 10 years
• A1c no more than 10.5%
• able to read and speak English (because non-English versions of the tests and the educational materials are not available)
• see link to clinicaltrials.gov for complete Inclusion criteria
• medical conditions that limit participation in study activities, as determined by the physician (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
• active alcohol or drug abuse
• seizure disorder unrelated to hypoglycemia, unless seizure-free for at 12 months and on stable therapy
• medical condition that requires intermittent or continuous use of glucocorticoids
• women who are pregnant, planning to become pregnant or are breastfeeding
• hospitalized for mental illness in last year
• see link to clinicaltrials.gov for complete Exclusion criteria
A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)
Nerandomilast is being developed to treat lung fibrosis. This study is to test a drug called nerandomilast in people with SARD-ILD who also take an immunosuppressant medicine. Participants are put into 2 groups randomly, which means by chance and will receive either nerandomilast or placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any study drug. Participants will be in the study for about 7.5 to 13 months depending on when they join the study.
• diagnosis of systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD)
• lung function has not improved with immunosuppressant (IS) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• active vasculitis
• suicidal behavior in the past 2 years
• see link to clinicaltrials.gov for complete Exclusion criteria
COG ACNS1833 - A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
The overall goal of this phase 3 non-inferiority study is to assess if selumetinib works as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with low-grade glioma (LGG).
• 2 to 21 years old
• all tumors considered low-grade glioma or low-grade astrocytoma
• patients with metastatic disease or multiple independent primary LGG are eligible
• patients must have the ability to swallow whole capsules
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)
People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.
• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Monoclonal Gammopathy and Amyloidosis Registry and Biobank (MGARB)
The purpose of this study is to establish a registry and biobank to study monoclonal gammopathy and amyloidosis. We aim to understand better the changes these diseases cause, the symptoms they present, and the clinical progression to be able to better prevent them and treat them in the future.
• diagnosis of monoclonal gammopathy or amyloidosis
• unable to speak English
The Women Kidney Program
The purpose of this study is to capture clinical information on how kidney disease affects the health of women, focusing on menstrual and reproductive health, the transition to menopause (the time when your menstrual periods stop permanently), and menopause itself. We also wish to learn more about how women’s health affects their kidney disease, bone and heart health.
• female as biological sex
• diagnosis of a kidney disease or after kidney transplant
• at least 18 years old
• unable to speak English
A placebo-controlled, randomized clinical trial to assess the safety, feasibility, and pharmacokinetics of Microbiota transplant therapy with antibiotic preconditioning and fiber supplementation in patients with pulmonary arterial hypertension
There is evidence that the gut microbes interact with the body’s immune system, and people with pulmonary hypertension may have altered composition of gut microbes. We are studying whether transplanting gut microbes from healthy donors using a treatment called microbiota transplant therapy may have beneficial effects on pulmonary arterial hypertension.
• ages 18-75
• diagnosis of pulmonary arterial hypertension (PAH)
• on stable treatment for PAH for one month prior to enrollment
• able to swallow capsules
• able to provide blood sample and fecal sample
• active inflammatory bowel disease or celiac disease
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• on immunosuppressants (calcineurin inhibitors, prednisone at a dose of 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
• history of solid organ or bone marrow transplant
• anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
• history of severe anaphylactic food allergy
• receiving cancer chemotherapy, immunotherapy, or radiation
COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)
This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.
• between 11 years and 45 years old
• confirmed germ cell tumour (non-seminoma or seminoma) OR Exceptionally raised tumour markers (AFP equal or greater than 1000ng/mL and/or HCG equal or greater than 5000 IU/L)
• primary arising in testis, ovary, retro-peritoneum, or mediastinum
• metastatic disease or non-testicular primary
• see link to clinicaltrials.gov for completed Inclusion/Exclusion criteria
• other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
• significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
• peripheral neuropathy equal or greater than grade 2 or clinically significant sensorineural hearing loss or tinnitus
CureGN: Cure Glomerulonephropathy Network
There are several different types of glomerular diseases. Glomerular diseases may affect how well your kidneys work. In this clinical study, we are studying four glomerular diseases: Minimal Change Disease (MCD), Focal Segmental Glomerulosclerosis (FSGS), Membranous Nephropathy (MN), and Immunoglobulin A Nephropathy (IgAN). These kidney diseases are rare. This makes it hard for researchers to find enough people to study these diseases. The goal of CureGN is to bring together a large group of people with glomerular diseases and collect and store important information so researchers can learn more about these diseases. We do this by collecting samples like your blood and urine and storing them in a repository. A repository is like a library, but instead of books, it stores data and samples, in an organized way. After approvals, researchers can use these samples and data to study glomerular diseases. The main goal is to help scientists find better ways to diagnose and manage the diseases and discover new treatments.
• Diagnosis of MCD, FSGS, MN, or IgAN diagnosed with a kidney biopsy in the last 5 years
• biopsy report or slides available
• diagnosis of End Stage Kidney Disease (ESKD), defined as chronic dialysis or kidney transplant
A Phase 1B/2 pan-tumor, open-label study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXD) in subjects with recurrent or metastatic solid tumors (IDeate-Pantumor02)
The purpose of this study is to learn more about an investigational drug called ifinatamab deruxtecan (I-DXd; DS-7300. It is being studied to see if it is safe, and if cancer improves while taking it. I-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumor cells to deliver chemotherapy directly to tumor cells while sparing healthy cells.
• disease progression on or after the previous standard-of-care regimen for advanced/metastatic cancer
• unable to do strenuous activity but able to walk and do work of a sedentary nature, e.g., light house work, office work
• additional criteria required based on the type of cancer (pancreatic, breast, bladder, etc.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
• clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
There is evidence that a short daily resisted breathing exercise, called inspiratory muscle strength training, can lower blood pressure and improve cardiovascular health. However, the most effective inspiratory muscle strength training protocol has not been established. This study seeks to test different training protocols. Participants will perform inspiratory muscle strength training daily, for 6 weeks. Each day's training will take less than 15 minutes to complete. Cardiovascular function will be measured before and after the 6-week training period.
• Non-smoking (not smoking cigarettes or vaping over the past year)
• Resting systolic blood pressure at or greater than 120 mmHg
• Free from serious cardiovascular or metabolic diseases
• English-speaking with ability to comprehend study materials and instructions
• Willing to comply with pre-visit instructions (avoiding food and caffeine ≥ 3 hours, vigorous exercise, alcohol, and non-prescribed medications ≥ 24 hours) prior to each measurement visit
• History of cardiovascular disease, or conditions affecting the ear (e.g., ruptured eardrum)
• Recent abdominal surgery or presence of an abdominal hernia
• Asthma with very low symptom perception, frequent severe exacerbations, or abnormally low perception of dyspnea
• Pregnant or planning to become pregnant during the study period
A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects with FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The purpose of this study is to look at the safety and efficacy of neoadjuvant ( before surgery) carboplatin and mirvetuximab soravtansine for women who have folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational drug designed to selectively kill cancer cells. All participants will receive an intravenous infusion of MIRV in combination with carboplatin for up to 6 - 9 Cycles
• may not be able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer
• see link to clinicaltrials.gov for complete inclusion criteria
• have been treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin
• previous clinical diagnosis of noninfectious interstitial lung disease
• eye conditions requiring ongoing treatment/monitoring
• history of another malignancy within past 3 years
Development of a RET-Specific Proteomic Assay from Circulating Tumor Cells in Lethal Prostate Cancer
The goal of this study is to find a special protein in the blood of individuals with serious prostate cancer. Special tests look for this protein in their blood while they are getting their regular cancer treatments.
• diagnosis of metastatic castration resistant prostate cancer receiving a standard-of-care systemic therapy (e.g. abiraterone acetate, enzalutamide, darolutamide, or chemotherapy).
• known HIV positivity and/or active Hepatitis B based on medical history
Prevalence of "funky" urine in lower urinary tract reconstruction utilizing bowel or catheter-based bladder management
This study is about improving our ability to characterize the prevalence of “funky” urine (i.e., urine with an abnormal odor, color, or appearance) in adults with either (1) a history of lower urinary tract reconstruction utilizing bowel and/or (2) catheter-based bladder management. We also aim to determine the frequency with which such patients receive antibiotic treatment for presumed urinary tract infections (UTIs). This may help us better understand how to help patients avoid unnecessary treatment with antibiotics.
• people who have catheter-based bladder management including an indwelling catheter (urethral or suprapubic, or a channel) or do intermittent clean catheterization OR
• have lower urinary tract reconstruction utilizing bowel including Ileal conduit, neobladder, bladder augmentation, or a catheter channel
• willing to share mobile phone number and use this for contact with the study team
PEPN2415; A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149, IND# 172675) when Combined with Focal Radiation in Pediatric Patients with High Grade Glioma
The primary purpose of this study is to define the recommended Phase 2 dose of AZD1390 when given in combination with radiation for pediatric supratentorial and infratentorial high-grade gliomas. The toxicities, safety profile and pharmacokinetic profile of AZD1390 in this setting will also be assessed.
• For the dose escalation phase, patients must be ≥ 12 months and < 18 years of age at the time of study enrollment.
• For the disease expansion phase, patients must be ≥ 12 months and < 22 years of age at the time of study enrollment.
• Patients with newly diagnosed primary High-Grade Glioma, Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma who are eligible to receive 54-59.4 Gy fractionated radiation at 1.8 Gy/day.
• Patients must have had histologic verification of malignancy at original diagnosis except in patients with DIPG.
• Patients who are pregnant or breast-feeding.
• Patients who are currently receiving another investigational drug.
• Patients receiving prior therapy for any cancer diagnosis (including radiation) is not allowed with the exception of surgery and/or corticosteroids.
• Patients who are currently receiving other anti-cancer agents are not eligible with the exception of corticosteroids.
• Anti-GVHD agents post-transplant: Patients who are receiving anti-graft-versus-host disease post bone marrow transplant.
Proteomics of Post-Operative Complications in Patients undergoing CABG
This study aims to identify independent blood-based risk factors for postoperative complications and near-term events among patients undergoing CABG surgery. In particular, this study will be using proteomics, the study of all proteins produced by the cells found in blood, as well as genetic analysis to identify potential predictive markers of postoperative complications. We will collect blood samples from before and after surgery. This study does not involve any medical treatment other than the one prescribed by your doctor, nor does it involve any additional medical procedures.
• Undergoing CABG procedure at MHealth Fairview hospital
• 45-80 years of age
• high risk patient as determined by the Society of Thoracic Surgeons (STS) Risk Assessment Score after designated number of patients have been included (study staff will review)
Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Perception of Affordances in Children with and without developmental coordination disorder
This study looks at perceptual abilities in healthy children and children with significant movement difficulties, a condition called developmental coordination disorder (DCD). The study involves a single session of using virtual reality (VR) to look at catching skills. This will help us to better understand movement difficulties in children so we can design programs to support them.
• children aged 11-17 years old with and without movement difficulties
• medical, behavioral, neurological or psychiatric conditions that prevent them from doing fine and gross motor activities
• children who are unable to communicate in English
Vasomotor symptoms of menopause and cardiovascular disease: What is the link?
Study to examine the physiological responses that occur during a hot flush in postmenopausal women
• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ≥ 35 kg/m2
Eye gaze patterns during audiovisual speech perception and natural conversation
The purpose of this research is to better understand how listeners take advantage of visual cues to support speech perception during conversations. Experiments will characterize these gaze strategies, describe how they vary with hearing ability and conversational context, and examine how differences in gaze behavior relate to listening effort during conversation.
• Be fluent in English
• Have normal or corrected-to-normal vision
• Have normal hearing OR Use a hearing aid
• Any vision disorders
• Cochlear implant
• Single-sided deafness
A Study to Determine the Prevalence and Clinical Characteristics Associated With PKD1 Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic disease which causes cysts to form in the kidneys. Over time as the cysts grow, the kidneys are not able to function the way they should, and may eventually lead to kidney failure. Certain people have a higher risk of developing ADPKD due to their genetic makeup. This study seeks to understand how often different types of PKD1/2 variations occur and the symptoms of ADPKD that people with PKD1/2 variants have. No study drug or devices will be administered.
• adults age 18-65
• pediatric patients age 12-17
• diagnosis of Autosomal dominant polycystic kidney disease (ADPKD)
• history of solid organ or bone marrow transplantation or nephrectomy
• ongoing renal replacement therapy or planning to start renal replacement therapy <12 months from the Genotyping Visit
Evaluation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) resistance in the tumor tissue of Non-small cell lung cancer (NSCLC) patients
This study is about discovering how Non-small cell lung cancer becomes resistant to EGFR TKI targeted therapy in order to predict and prevent this cancer from not responding to treatment.
• Age 18-85 years
• confirmed advanced adenocarcinoma of the lung
• identified EGFR mutation
• treatment with osimertinib
• radiation or other drug treatments other than osimertinib
Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients receiving Neoadjuvant Chemotherapy with Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer who are Folate Receptor positive
The purpose of the study is to document the feasibility of undergoing surgery for cancer after receiving 3 cycles of neoadjuvant chemotherapy carboplatin and mirvetuximab soravtansine as first-line treatment in patients with advanced-stage ovarian cancer that are Folate Receptor alpha positive.
• confirmed high grade serous epithelial ovarian cancer
• stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy (before surgery)
• strenuous activity may be restricted but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 4 months after the last dose
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• previously treated with a systemic anti-cancer therapy
• low-grade serous, endometrioid, clear cell, or mucinous cancer
• women who have active or chronic corneal (eye) disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision
• history of hepatitis B or C infection or human immunodeficiency virus (HIV) infection
• women who are pregnant or breastfeeding
• history of other cancer within 3 years prior
• significant heart, lung, liver disease
A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.
• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)
This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.
Sleep Outcomes with DBS Therapy in Parkinson's Disease and Dystonia
The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.
• at least 21 years old
• existing or planned 7T brain imaging
• surgery at UMN to implant DBS system planned as part of routine clinical care (or has already occurred, as long as the first programming session is at least 2 weeks away)
• other significant neurological disorder
• history of dementia
• complications after surgery
• women who are pregnant
Udall P1A4
Through this research, the study staff hopes to better understand how DBS works and to define the optimal site in the brain for DBS treatment for Parkinson’s Disease. You will be asked to come for one study visit where you will perform some physical and mental tasks while on and temporarily off your medications and DBS treatment. Participation in this research study will take 7-8 hours.
• at least 10 years old
• diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
• implanted Deep Brain Stimulator (DBS)
• have a 7T MRI
• history of dementia
• women who are pregnant or breastfeeding
• other exclusion criteria (study staff will review)
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