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Primary Dysautonomias clinical trials

View clinical trials related to Primary Dysautonomias.

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NCT ID: NCT05834829 Not yet recruiting - Clinical trials for Autonomic Dysfunction

Low-intensity Focused Ultrasound and Autonomic Response

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal anterior insula (dAI) and dorsal anterior cingulate cortex (dACC) on autonomic control using three tests to probe the autonomic system. A cold pressor task, valsalva maneuver, and deep breathing tasks will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.

NCT ID: NCT05664854 Not yet recruiting - Epilepsy Clinical Trials

Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

EITsVNS
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Electroceuticals is a new field in which the goal is to treat a wide variety of medical diseases with electrical stimulation of autonomic nerves. A prime target for intervention is the cervical vagus nerve as it is easily surgically accessible and supplies many organs in the neck, thorax and abdomen. It would be desirable to stimulate selectively in order to avoid the off-target effects that currently occur. This has not been tried in the past, both because of limitations in available technology but also because, surprisingly, the fascicular organisation of the cervical vagus nerve is almost completely unknown. The aim of this research is to investigate the functional anatomy of fascicles in the cervical vagus nerve of humans. This will include defining innervation to the heart, lungs and recurrent laryngeal and, if possible, the oesophagus, stomach, pancreas, liver and gastrointestinal tract. It will be achieved by defining fascicle somatotopic functional anatomy with spatially-selective vagus nerve stimulation (sVNS) and the new method of fast neural imaging with Electrical Impedance Tomography (EIT). EIT is a novel imaging method in which reconstructed tomographic images of resistance changes related to the opening of ion channels over milliseconds can be produced using rings or arrays of external electrodes. In humans, using a nonpenetrating nerve cuff with sVNS or fast neural EIT, this will be performed for 30 minutes transiently during an operation to insert a vagal nerve stimulator for treatment of epilepsy and deliver images in response to activity such as respiration or the electrocardiogram (ECG).

NCT ID: NCT05369520 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Noninvasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury

Start date: January 2023
Phase: N/A
Study type: Interventional

This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).

NCT ID: NCT05315739 Not yet recruiting - Fatigue Clinical Trials

Vagus Nerve Stimulation for Systemic Lupus Erythematous

SLE-VNS
Start date: May 2022
Phase: N/A
Study type: Interventional

This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in patients with systemic lupus erythematosus (SLE). The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue. Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic nervous system function, SLE disease activity, immunologic profile, tolerability of pain and organ (cardiac, vascular and kidney) functions. Participants are randomized to received either active non-invasive transcutaneous vagus nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods. The first period investigates the effects of short-term, high-intensity tVNS treatment. The second phase investigates the effects of long-term, middle-intensity tVNS treatment.

NCT ID: NCT05098977 Not yet recruiting - Clinical trials for Myocardial Infarction

The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction

HeaRt-V-AMI
Start date: November 2021
Phase:
Study type: Observational

Aims - heart rate variability (HRV) assessment in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention (PCI); - measurement of HRV using a device approved for medical use in Europe; - assessment of the correlation between HRV and short- and long-term adverse cardiovascular events (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease) in patients treated by primary PCI for acute myocardial infarction; - creating a registry of HRV parameters measured in a contemporary cohort of patients with acute myocardial infarction.

NCT ID: NCT05087953 Not yet recruiting - Clinical trials for Autonomic Nervous System Disease

Autonomic Evaluation of Patients With Hereditary Amyloidotic Cardiomyopathy: Hereditary Amyloidotic Heart Disease

Start date: January 2022
Phase:
Study type: Observational

Transthyretin amyloidosis exhibits a variety of possible phenotypes, the hereditary neurological form being the most commonly found and studied (familial amyloidotic polyneuropathy or FAP), which can present from oligosymptomatic patients to patients with peripheral sensorimotor polyneuropathy of varying degrees and dysautonomia. Although a specific mutation usually causes a specific phenotype, that is, with a predominantly cardiac or preferential neurological profile, with the increase in the number of diagnosed cases, an overlapping of clinical presentations has been observed. The assessment of the autonomic profile in individuals with familial amyloidotic cardiomyopathy (FAC) has not been well studied, and it is not known whether patients with an exclusively cardiac profile of the disease may present dysautonomia or whether even mutation carriers without cardiac involvement may exhibit it. In this study, the autonomic profiles of patients with familial amyloidotic heart disease will be compared with the profiles of patients who have mutations but without established heart disease and healthy individuals (control group).

NCT ID: NCT04964921 Not yet recruiting - Diabetes Clinical Trials

Distinguishing Patient Groups Using Autonomic Dysfunction

Start date: December 2021
Phase:
Study type: Observational

A study population with impaired fasting glucose levels, impaired glucose tolerance levels and diabetes (with or without complications) along with healthy patients will be chosen as participants. Their vital signs and their ECG (electrocardiograph) will be recorded during their only visit. Data analysis will be performed using the vital signs parameters. The RR intervals from the ECG will be analyzed by 5 different techniques to determine the best technique that stratifies the subjects the most accurately.

NCT ID: NCT04502199 Not yet recruiting - Dysautonomia Clinical Trials

Dysautonomic Phenotype in Male Patients With MECP2 Mutation

MECP2BOYS
Start date: August 15, 2020
Phase:
Study type: Observational

Dysautonomic signs are well known among girls with a Rett Syndrom. Rett syndrom is caused by a MECP2 mutation in 95% of cases. We want to search dysautonomic signs among boys with a MECP2 mutations because they are less studied than the girls and they have more varied phenotypes.

NCT ID: NCT02365974 Not yet recruiting - Hypertension Clinical Trials

Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure

TENS
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Uncontrolled blood pressure represents the main factor in the development of target organ lesions and, consequently, cardiovascular events, which are the leading cause of morbidity and mortality worldwide. In most cases resistant hypertension is preceded by target organ lesions, and is strongly influenced by risk factors or associated diseases. To control this disease requires an adequate and intense therapeutic approach that includes lifestyle changes and the use of several antihypertensive drugs. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of resistant hypertension (RH), two, sympathetic overstimulation and therapies that block the sympathetic system, have been widely studied. But, these approaches are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a non-invasive method that modulates activity by inhibiting primary afferent pathways using low-frequency transcutaneous electrical stimulation. Some studies have shown that TENS reduces blood pressure in patients with hypertension. The current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low cost and readily available therapy to treat this group of hypertensive individuals.