The goal of this clinical trial is to learn if the cueStim device can reduce the duration of freezing of gait (FoG) that occurs in patients with Parkinson's Disease. The study will compare two modes of operation of the cueStim device; both modes of operation use the same wearable device. The purpose of the study is to compare how the two modes affect symptoms across study participants. Because this is a research study, it is not yet known whether either mode reduces symptoms.
Participants will:
* Be randomized to one of the two modes available on the cueStim device
* Wear the device for 4 weeks as they go about their daily life
* Complete daily diary entries to document symptoms, falls and overall experience
* Check-in with the clinical site throughout participation
* Complete a final follow-up visit
Parkinson's Disease With Freezing of Gait· Fortis Medical Devices Limited· Boca Raton, Florida · Daytona Beach, Florida +3 more· Ages 60–90
Patients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability to inhibit actions.
The Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching for genes that increase the risk of developing Parkinson's disease (PD) and related disorders. The study is a joint effort by neurologists and researchers across the United States and is sponsored by the National Institutes of Health. The coordinating center for PaGeR is located at the University of Washington and the VA Puget Sound Health Care System in Seattle.
Parkinson's Disease· University of Washington· Atlanta, Georgia · Cincinnati, Ohio +2 more
The purpose of this study is to understand how prism adaptation training with and without electrical stimulation changes visuospatial behavior, motor system neurophysiology, and walking dysfunction.
Stroke is a leading cause of long-term disability. Research has placed little emphasis on integrating care partners (CP) (family members) into the rehabilitation process without increasing negative care partner outcomes. The research team has developed and implemented a novel, web-based care partner-focused intervention (CARE-CITE) designed to foster problem-solving and skill building while facilitating care partner engagement during stroke survivor (SS) upper extremity practice of daily activities in the home setting. By providing a family-focused approach to rehabilitation interventions, this project will help develop more effective treatments that improve CP and outcomes after stroke.
Stroke survivors with lower limb disability can improve their walking speed with high-intensity interval training (HIIT) rehabilitation therapy. However, some individuals may not respond to HIIT even when fully adherent to the program. To address this, the investigators propose to build a predictive model that identifies if a Veteran with chronic subcortical stroke will improve their walking speed with HIIT by incorporating blood lactate as an early predictor of exercise response, and inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and regional cerebral blood flow (CBF) as predictors of the brain's potential to respond, while also taking into consideration other factors such as comorbidities, demographics, and fitness levels.
Stroke· VA Office of Research and Development· Decatur, Georgia· Ages 18–89
After a right brain stroke, \>50% of Veterans experience problems with dressing, eating, self-care or steering their wheelchairs because their ability to move, orient, and respond toward the left side is limited: spatial neglect. Spatial neglect prevents them from functioning independently, and their needs in the hospital and at home are greatly increased. An effective treatment for spatial neglect is 10 days of visuomotor training while wearing optical prisms (PAT), however many clinicians \[fail to diagnose spatial neglect and use this approach. In this study, the investigators will develop a brain scanning test that could objectively identify the Veterans with spatial neglect after stroke who are the best candidates to receive PAT and recover their ability to function. When the research is complete, the investigators expect that brain scans done in the hospital can guide the team to refer Veterans to PAT rehabilitation: improving daily life function\] and quality of life.
Spatial Neglect After Right Brain Stroke· VA Office of Research and Development· West Haven, Connecticut · Decatur, Georgia +2 more
This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive transcranial magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue and other clinical characteristics related to mood and cognition before and after participants receive rTMS.
Stroke· VA Office of Research and Development· Decatur, Georgia · Charleston, South Carolina· Ages 34–80
An exoskeleton device is a robotic system designed to improve an individual's ability to move and perform tasks encountered in everyday situations. These devices consist of external rigid limb segments that assists humans through different body movements with the use of actuators. These devices are controlled by an onboard computer that determines the timing and magnitude of assistance deployed to the user. Exoskeleton controller performance is key to providing beneficial assistance that does not inhibit the user's movement. Preceding work will compare the benefit of personalized hip versus ankle joint exoskeleton assistance for improvement of post-stroke gait. It will combine exoskeleton technology with the user's movement feedback to improve wearable robotic assistance to an individual stroke survivor's gait pattern. For the clinical trial research covered under this protocol, the investigator will test various exoskeleton technologies with stroke survivors in real-world contexts, indoors and outdoors, and measure clinically meaningful outcomes and user perceptions regarding technology usability and adoption. The long-term goal is to deploy self-adaptive, adoptable exoskeletons for personalized assistance during community ambulation.
Stroke· Georgia Institute of Technology· Atlanta, Georgia· Ages 18–85
This study aims to collect swallowing acoustics with a novel non-invasive wearable surface microphone device during routine work-up, videofluoroscopic swallow study (VFSS), of patients with dysphagia (swallowing trouble). The collected microphone data will be analyzed to find the pattern of abnormal swallowing by machine learning algorithm.
This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.
A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well
Ischemic Stroke· Raul Nogueira· Atlanta, Georgia · Iowa City, Iowa +2 more
This study aims to develop imaging-based biomarkers to assess which chronic stroke participant with lower extremity disability may respond or resist high intensity interval training (HIIT).
Previous research suggests that physical exercise training is safe and could help improve the walking speed of non-ambulatory stroke survivors. However, inter-individual variability in response to exercise is extraordinarily high regardless of adherence, and predictors of response remain elusive.
Chronic stroke survivors with lower limb disability resulting in slow walking speeds will participate in 12 weeks of cycling exercise at Emory University under the guidance of a physical exercise instructor, 3 days a week, for 25-60 minutes. During some of the exercise sessions, the investigators will collect blood lactate with a finger prick. Brain scans with an MRI before and after the 12 weeks of exercise will be done; motor function tests that include walking, sitting down, standing up, and turning around will be collected. Participants' memory and thinking will be assessed, and participants will fill out questionnaires about their health before and after their stroke, and well as questions about their diet.
The participation will last between 14-16 weeks (up to 42 study visits).
The investigators will study whether the drug tadalafil improves shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the Veteran nor the investigator will know whether the Veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.
Chronic Obstructive Pulmonary Disease· VA Office of Research and Development· Aurora, Colorado · Decatur, Georgia +3 more· Ages 35–89
The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:
• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.
Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo).
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
Postpartum Complication· University of Texas Southwestern Medical Center· Atlanta, Georgia · Dallas, Texas
This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.
Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
Resistant Hypertension· DeepQure Inc.· Orange, California · Stanford, California +3 more· Ages 22–80