Syncope (Fainting)

About 20% of adults experience recurrent fainting, leading to significant symptoms, difficulties with work and driving, injuries, and reduced quality of life. Because few treatments have been proven effective in randomized trials, researchers are conducting a phase 2, randomized, double-blind study to test if blocking serotonin 5HT3 receptors with ondansetron can prevent fainting or near fainting caused by tilt-induced vasovagal syncope (VVS). This study aims to provide preliminary data for future larger trials. Participants will be randomly assigned to receive either two doses of ondansetron 8 mg by mouth (one the evening before and one the morning of the study) or matching placebo doses on separate days. After dosing, participants undergo a tilt table test where their heart rhythm, blood pressure, and blood samples will be monitored continuously for up to 60 minutes or until fainting occurs. Additional measurements include bioelectrical impedance to assess fluid shifts in the body during posture changes and questionnaires to evaluate quality of life, anxiety, and depression. During the study, participants will have ECG electrodes and a blood pressure cuff applied, along with an intravenous line for blood sampling. Blood samples will be collected at baseline and during the tilt test to measure catecholamine levels. Participants will also complete online surveys assessing health-related quality of life and mood symptoms. The main outcome is the time until fainting or near fainting within one hour. Secondary outcomes include stroke volume, cardiac output, vascular resistance, and psychological measures monitored during the study and within 12 months. The study lasts about one day for the tilt test and includes follow-up assessments up to one year.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Researchers are evaluating the Home Hazard Removal Program (HARP), adapted for people with disabilities (PwD), to prevent falls by identifying and removing hazards in the home. This pilot randomized controlled trial (RCT) will test how well the adapted HARP works and how it can be implemented for community-dwelling PwD. The study uses frameworks like RE-AIM and PRISM to guide adaptation, design, and evaluation, aiming for broad usefulness and dissemination of findings. Participants will be randomized into two groups: one receiving the adapted HARP intervention and the other placed on a waitlist control receiving virtual social visits. The adapted HARP involves two to three in-home visits by an occupational therapist over about five weeks to identify fall hazards and collaboratively create solutions. Additional visits and a contractor, if needed, help implement home modifications, all provided at no cost. Booster visits occur 3 to 6 months later to check and support ongoing home safety. Participants will be followed for 12 months, with monthly tracking of falls, fall-related injuries, and home modifications. Fear of falling is assessed at the start and end of the study. Researchers will collect quantitative and qualitative data, including interviews and focus groups, to evaluate hazard types, costs, adherence to modifications, and barriers to adoption. The total study duration includes the intervention and follow-up to monitor safety and effectiveness in everyday home settings.

Diabetes Mellitus, especially type 2, is a widespread condition often leading to Diabetic Peripheral Neuropathy (DPN), which affects sensation and muscle control in the feet, legs, hands, and arms. This condition can cause symptoms like pain, numbness, and balance problems, increasing the risk of falls. This research aims to assess whether adding Proprioceptive Neuromuscular Facilitation (PNF) exercises to the Otago Exercise Program can improve balance, reduce fear of falling, and enhance sensory function in people with DPN. The study compares two groups: one follows the Otago Exercise Program alone, which includes 14 strengthening and balance exercises targeting leg muscles and walking skills; the other group combines Otago exercises with PNF, a method involving diagonal and spiral movement patterns designed to improve neuromuscular control through progressive resistance. Both interventions are delivered in sessions lasting 40 to 50 minutes, three times a week, over six weeks. Participants will be evaluated using measures such as the Berg Balance Scale, Fall Efficacy Scale, Functional Reach Test, and Semmes Weinstein Monofilament Test at the start and end of the six-week program. Screening includes the Michigan Neuropathy Screening Instrument and Berg Balance Scale to confirm eligibility. The study will document changes in balance, fear of falling, and sensory function to understand the effects of the exercise protocols on fall risk in this population.

Researchers are evaluating an investigational artificial intelligence (AI) software designed to estimate the severity of ejection fraction (EF), which indicates how well the heart pumps blood. This prospective, multicenter, cluster-randomized controlled study compares EF severity categories determined by the AI software using continuous ECG waveform data to those measured by an FDA-cleared transthoracic echocardiogram (TTE). The study aims to provide a low-burden, cost-effective alternative for EF monitoring in heart failure and related heart conditions, especially where traditional imaging access is limited. Participants will use the FDA-cleared Peerbridge COR4 ECG Wearable Monitor, a patch device worn during daily activities, to collect ECG data. During a 15-minute resting session while seated upright, 5-minute ECG segments will be recorded and analyzed by the AI software to estimate EF severity based on the American Society of Echocardiography's scale. The study includes two subprotocols: one with 30 minutes of ECG recording including 15 minutes analyzed, and another allowing up to 7 days of device use with periodic sitting sessions. The EF severity from the AI software will be compared against results from echocardiography. Participants will be enrolled at multiple sites, providing paired data points consisting of simultaneous or near-simultaneous ECG recordings and echocardiograms. They will follow a standardized 15-minute seated session protocol using the wearable device, pressing an event button to mark the session start and end. Data collection includes medical histories, 12-lead ECGs, and device logs. The main outcome measures focus on agreement between the AI software's EF severity categories and those from echocardiography over an average of 9 months. Safety and compliance will be monitored throughout the study period.

This research focuses on patients experiencing stiff knee gait (SKG), a condition caused by spastic muscle complications in the leg that can result from stroke, brain injury, spinal cord damage, or multiple sclerosis. SKG affects the mobility of the knee joint, leading to stiffness that hampers walking ability. The study aims to observe and compare balance and risk of falls before and after treatment with botulinum toxin injections in the rectus femoris muscle, which is a current standard treatment to reduce muscle spasticity in these patients. Participants will receive botulinum toxin injections targeted to the rectus femoris muscle. The study is observational and will evaluate the effects of these injections on balance and walking ability without altering standard care. Functional clinical tests such as the Time Up and Go test, Berg Balance Scale, Stair Climb and Descent Time test, and a questionnaire about the number of falls will be used to assess participants before and four weeks after the injections. Throughout the study, participants will undergo these clinical tests to measure static and dynamic balance and walking function. Researchers will specifically focus on the Time Up and Go test as the primary outcome four weeks after treatment. Secondary outcomes include balance scale scores, stair climbing times, and fall frequency. The study will also monitor safety and compliance. The total study duration for each participant is at least four weeks from the inclusion visit to the post-injection evaluation.

Researchers are exploring how deep brain nuclei activity and the cerebral cortex function during recovery from general anesthesia in patients undergoing deep brain stimulation (DBS) surgery. This study aims to understand the changes and connections between deep brain nuclei firing and cortical activity during the return of consciousness. The research focuses on the brain's neural networks involved in recovery, which is not just a passive drug clearing process but an active brain function. During the study, patients having DBS surgery will have their local field potentials (LFP) from deep brain nuclei and scalp electroencephalograms (EEG) from the frontal cortex recorded simultaneously. No additional interventions are given beyond the planned DBS surgery. These recordings occur during the recovery period after general anesthesia to analyze how signals from deep brain areas relate to cortical EEG activity. Participants will be monitored for changes in brain signals over about 2 hours during recovery from anesthesia. Researchers will evaluate the number of patients showing changes in LFP and EEG patterns. The study includes assessments of brain activity to better understand consciousness recovery mechanisms. Patients are expected to cooperate during surgery and recording, with the total observation focused on the immediate post-anesthesia recovery phase.

Researchers are evaluating the benefit of adding tilt table testing to biofeedback and standard care in patients with certain or highly likely vasovagal syncope. This condition causes fainting due to a sudden drop in heart rate and blood pressure. The trial aims to compare outcomes between patients receiving biofeedback with tilt table testing and those receiving biofeedback without tilt table testing, as current evidence on the value of tilt table testing is lacking. Participants are randomly assigned to one of two groups: one group receives biofeedback and standard care along with tilt table testing, while the other group receives biofeedback and standard care without tilt table testing. Tilt table testing is used as a diagnostic tool to provoke syncope under controlled conditions. The study explores whether this provocation improves patient management and outcomes. During the study, participants will be monitored for syncope recurrence, time until the first syncope event, near-syncope episodes, health technology assessments, and quality of life over a 12-month follow-up period after enrollment. Researchers will collect data on these outcomes to evaluate the impact of tilt table testing on the condition. The study is scheduled to begin in October 2025 and continue until March 2028.

This research focuses on older adults aged 60 to 85 who have a high risk of falling. Falls are a major cause of injury, loss of independence, and even death in this population, especially slip-related falls that often lead to hip fractures or head injuries. The study aims to develop personalized training programs to reduce fall risks by understanding individual biomechanical causes of falls and providing targeted rehabilitation. Participants will undergo specific balance and muscle strengthening training both in the lab and at home. The lab sessions, held once weekly for six weeks, use a sliding stepping fall rehabilitation system that targets directions where participants showed higher fall risks. At home, participants will do walking exercises monitored by a cellphone app that provides real-time feedback on body sway, or strength training using selected exercise machines to improve lower limb stability. Participants will be assessed before and after the six-week training period and again two months later to evaluate fall risk, muscle strength, gait forces, body movement, and reactions to balance disturbances. Safety measures such as a harness system during lab training and family support at home help protect participants. The total study duration includes these assessments and training, with ongoing monitoring to track progress and adjust exercises as needed.

Researchers are studying how different heart rates affect stroke volume and cardiac output in patients with vasovagal syncope who have permanent pacemakers. This study aims to clarify how increasing heart rate impacts the heart's ability to fill with blood and pump effectively, both when lying down and when upright. The investigation addresses a gap in understanding the relationship between heart rate and cardiac function in this group. The study involves pacing the heart at various rates ranging from 50 to 130 beats per minute while monitoring stroke volume and cardiac output using non-invasive methods. After completing pacing runs while lying down, participants rest for 10 minutes before being tilted upright at an angle greater than 70 degrees for about 10 minutes, followed by additional pacing sessions. Blood pressure is measured and the equipment calibrated between pacing runs. Participants will undergo assessments that include continuous monitoring of stroke volume and cardiac output during different pacing rates and positions. The primary outcome is the change in cardiac output during atrial pacing at different rates while lying down. Secondary outcomes include changes in cardiac output and stroke volume during various pacing modes and body positions. The entire study procedure occurs within one day, and safety is ensured by using non-invasive techniques and secure positioning during upright testing.