Featured below are ongoing studies related to dysautonomia and POTS related illnesses. DINET does its best to select the studies that we believe will best appeal to our community. If you know of a study that you would like to share with DINET, please email the information with the link to the study, to firstname.lastname@example.org All information will be reviewed.
Open Recruitment Studies (updated May 2020)
*****RECRUITING COVID-19 STUDIES:
Patient research: NIH supported research is being conducted by the Rare Disease Clinical Research Network on the impact that the COVID pandemic is having on people living with rare diseases. You do NOT have to have been tested for COVID or have had symptoms of illness, the only criteria is to be under 90 years old and to have a rare disease. Caretakers or parents of children with rare diseases are also encouraged to participate. Read more about the goals of the study and the process at this link: https://www.rarediseasesnetwork.org/COVIDsurvey
Neurology research: New research study conducted by Dr. Blitshteyn to examine the impact of COVID-19 on patients with pre-existing neurological disorders including POTS, OH, MSA, Neuropathy and Chronic Migraine. The study includes a 5 min anonymous survey that a patients neurologist would fill out. Please share this survey with your neurologist if you have tested positive for COVID-19 and you are being treated by a neurologist for the disorders listed.
***RECRUITING: DINET has partnered with PCORI (Patient-Centered Outcomes Research Institute), the University of Pittsburgh and the University of Pittsburgh Medical Center in the Story Booth project. Research is crucial to helping us further our understanding of POTS and other forms of dysautonomia and to identify ways to prevent or cure these conditions. That's why DINET is parterning with the Patient-Centered Outcomes Research Institute (PCORI) and the University of Pittsburgh on their MyPaTH Story Booth Project. The project aims to help researchers better understand the dysautonomia patient experience with illness, coping and the healthcare system. Researchers hope their findings will lead to the development of reserach studies that address topics that are important to patients and caregivers. Please visit our Story Booth page for more detailed information or to get started sharing your story. https://www.dinet.org/member-stories/story-booth-project-sharing-the-stories-of-patients-and-caregivers-r209/
RECRUITING: John Hopkins University is examining the use of a temporary celiac ganglion block before celiac ganglion resection in dysautonomia-related bowel dysmotility. Autonomic celiac ganglia resection has been shown to alleviate symptoms of dysautonomia-related dysmotility by interrupting the sympathetic stimulation to the GI system. Currently there has been no test to confirm this diagnosis pre-surgery. This studies objection is to temporarily block the ganglion to see if the symptoms go away, therefore confirming diagnosis and allowing for the more permanent surgical action. This study is recruiting patients with chronic dysmotility who are considering Celiac Ganglion resection. For further criteria and information about this study, please visit:
Contacts: Christos Georgiades, MD PHD email@example.com
Beatriz Kohler, firstname.lastname@example.org
RECRUITING: Clarkson University is conducting a study to learn about what factors affect the function and quality of life for people living with various chronic illnesses. The study should take approximately 45 minutes to complete and asks similar questions to those asked by healthcare providers. Questions will include quality of sleep, fatigue, pain, etc. All answers will be anonymous. Participants must be 18 years or older. Each person participating is requested to ask one healthy person to also participate but this is not required. To learn more about this study or to begin the questionnaire, visit https://www.surveymonkey.com/r/V3P7S9J This is an IRB exempt study.
RECRUITING: A study is being conducted to examine the affect on parents who are raising a child with POTS. This study is being conducted through the University of Mississippi, under the Principle, Abigail Armstrong for her Master's thesis. Abigail is a POTS patient and DINET member.
This is an IRB approved study.
You must be a parent or primary caregiver of a child 8 - 17 years of age who has been diagnosed with POTS
The child's diagnosis must have been made 6 months ago or longer
You must be able to speak and read English proficiently
This study will be conducting completely online and will take 10 - 15 minutes to complete. The purpose of this study is to better understand the impact POTS has on the parents and the child. The study will ask you to complete a series of brief questionnaires about yourself, your experiences as a parent, and your child diagnosed with POTS.
Please email Abigail with any questions about the study at email@example.com
To begin the study, click on the link provided: https://usmep.co1.qualtrics.com/jfe/form/SV_cIpzp1ncQXLJdad
RECRUITING: Vanderbilt University is conducting a study entitled "Pathophysiology and therapy of Orthostatic Intolerance." Studies to identify the role of the brain, the autonomic nervous system and the vasculature in Orthostatic Intolerance. Blood pressure and HR are measured laying down and standing at regular intervals. Blood samples are drawn for hormones affecting blood pressure control. Some studies require tilt table testing and medication administration.
Eligibility: All participants are adults.
Principles: David Robertson, M.D., Bonnie Black, RN
Vanderbilt University, Clinical Research Center
RECRUITING: Clinical Trial: Dr. Satish Raj and the University of Calgary is recruiting POTS patients for a study of the effects of compression on the symptoms of POTS
OPEN ENROLLMENT: The Mayo Clinic is conducting a study to better understand the causes of autonomic disorders. The study includes the collection of DNA for future studies. This study is being conducted in part by Dr. Philip Low, one of the leading researchers in this field.
Eligibility: Males and females (non-pregnant) age 13 years and older diagnosed with MSA, PAF, Autonomic Neuropathies, NOH, POTS, Dysautonomia and healthy participants. Orthostatic range must include a systolic BP deduction of > 30 mm Hg or mean BP reduction of > 20 mm Hg that occurs within 3 mins of head-up tilt.
For help understanding the criteria or for more information about the study, please contact Tonette Gehrking CAP at firstname.lastname@example.org or call 507-284-4462
Participating Clinics: Rochester, Minnesota.
RECRUITING: University of CA is studying the effect of the drug Ivabradine, a drug currently used for heart failure, to examine the possibility of its use as a treatment for heart rate issues in POTS patients.
University of CA, San Diego
Investigator: Pam Taub, MD
For more information: https://clinicaltrials.gov/ct2/show/NCT03182725?cond=Postural+Orthostatic+Tachycardia+Syndrome&rank=3
RECRUITING: Parent-Child Dyadic Experiences Living with Postural Orthostatic Tachycardia Syndrome (POTS) during Emerging Adulthood. What is it like living with POTS during emerging adulthood? Virginia Tech wants to know. If you are interested in joining a family science study on POTS, please contact Masumeh@vt.edu. Participants must be 18-29 years old, diagnosed with POTS. This is a parent-child study, so both must be willing to participate. Participants must reside in the U.S.
Virginia Polytechnic Institute and State University
Department of Human Development
Principal Investigator: Dr. Carolyn Shivers
Co-Investigator: Masumeh Farchtchi
Specifics about the study and a consent form will be emailed to you if you are interested.
ACTIVE NOT RECRUITING: Clinical Trial: University of Oklahoma and Vanderbilt University are recruiting POTS patients for the Autoimmune Basis for Postural Tachycardia Syndrome study. They are looking at the levels of immune proteins (autoantibodies) in POTS patients and their relation to symptoms over time. https://clinicaltrials.gov/ct2/show/NCT02725060?term=autonomic+dysfunction&cond=Postural+Orthostatic+Tachycardia+Syndrome&rank=5
Recruiting: Vitamin D Deficiency in Dysautonomia In previous work the investigator identified a group of children between the ages of 10-18 years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic intolerance, primarily defined as postural orthostatic tachycardia syndrome (POTS) (88%). While this is an atypical initial presentation for orthostatic intolerance in general, the investigator believes that the cardiovascular problem is serious and represents a cause of nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the tachycardia symptoms or the BRS suppression during HUT. Furthermore, it caused an elevation in MAP in a supine position, which may lead to future cardiovascular problems such as early onset hypertension and cardiac hypertrophy. This argues for a different treatment approach. The investigator presents preliminary data in this application revealing that OI subjects tend to have lower 25-hydroxyvitamin D (25(OH)D) compared to non OI subjects.
Open to children 10 - 18
Still Recruiting: ME/CFS Activity Patterns and Autonomic Dysfunction The purpose of this study is to identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and behavioral intervention trials, roughly 50% of patients report worsening or unchanged illness. The proposed four-year study would be the first to look at the relationship between illness non-improvement, patient activities at home and autonomic function. Our long-range goal is to identify physiological signals and activity patterns that predict non-improvement and relapse and develop a self-management program that prescribes improvement-linked behaviors and discourages non-improvement activities.
Contact: Particia Bruckenthal, PhD, RN 631-444-1172 email@example.com
Contact: Jenna Adamowicz, MA 631-371-4417 firstname.lastname@example.org
Recruiting: The investigators propose to conduct a safety, tolerability and early proof of concept efficacy study of phosphatidylserine in patients with FD. The long-term goal is to find an effection nutritional therapy that will improve the quality of life for patients with FD and alter disease prognosis Contact & participation information is available - https://clinicaltrials.gov/ct2/show/NCT02276716?cond=Dysautonomia&rank=5
Completed, Results TBA PET Imaging Study of Neurochemical and Autonomic disorders in Multiple System Atrophy (MSA) from the University of Michigan.
This study aims to better understand the patterns and timings of nerve degeneration relatively early on and how it affects symptoms and progression.
Eligibility: 30 - 80 years old
Gender: AllSubject: diagnosis of MSA or probable MSA of the Parkisonion subtype (MSA-P) or Cerebellar subtype (MSA-C), Subject must be willing and able to give informed consent. Normal cognition as assessed by MiniMental State Examination
Timeline: Less than 4 years from the time of documented diagnosis
See study online for exclusions and further information.
Contacts: Arijit K Bhaumik, B.A. CCRP, 734-936-8281 email@example.com
Edna Rose, Ph.D., RN, MSW, BC, 734-936-7359, firstname.lastname@example.org
Estimated Primary Completion Date: July 2018
Recruiting: A Study of Pyridostigmine in Postural Tachycardia Syndrome.
This is a 3-day study being conducted by the Mayo Clinic comparing pyridostigmine vs placebo in the treatment of POTS. Researchers expect pyridostigmine to improve tachycardia and stabilize blood pressure.
Eligibility: Diagnosis of Postural Tachycardia Syndrome using the following criteria:
Orthostatic heart rate increment greater than or equal to 30 beats per minute (BPM) within 5 minutes of head-up tilt.
Symptoms of orthostatic intolerance. These include weakness, lightheadedness blurred vision, nausea, palpitations, and difficulty with concentration and thinking.
Both criteria must be fulfilled
See study online for exclusions and further information
Mayo Clinic location, Rochester MINN, Principal Investigator: Dr. Philip Low
Contact: Tonette Gehrking, CAP, 507-284-4462, email@example.com
(Completed, Results TBA) The Safety and Tolerability of Kinetin, in Patients with Familial Dysautonomia
The overall objective of this study is to assess the safety and tolerability of administering kinetin in patients with FD. The specific aim of this proposal is to determine the safety of a once-daily dose of kinetin in patients with FD using a dose ascending titration and to determine the long-term safety and tolerability during 3-years of receiving a maximum tolerated steady state dose of kinetin. The investigators hope to also demonstrate early proof of concept that kinetin enhances the ability of the neuronal tissue to correctly splice IKAP mRNA.
Eligibility: Male or female 16 years of age and older, confirmed a diagnosis of familial dysautonomia by genetic testing, written informed consent to participate in the trial and understanding that they can withdraw consent at any time without affecting their future care. And the ability to comply with the requirements of the study procedures.
See study for more info and exclusions:
New York University School of Medicine
Estimated Completion date: September 2019
Contact: Horacio Kaufmann MD, 212-263-7225,firstname.lastname@example.org Contact: Jose Martinez, MA, 212-263-7225, email@example.com
Two new studies open for patients with MSA
The NYU Dysautonomia Center has 2 new clinical trials to test new drugs that are being developed for the treatment of OH in patients with MSA. Both compounds work by enhancing the body’s levels of norepinephrine. Both studies are also being carried out at the Autonomic Dysfunction Center at Vanderbilt University. NYU Dysautonomia Center and Vanderbilt are longtime collaborative partners in rare autonomic disorders.
(CLOSED RECRUITMENT) Study 1: A Phase 2 Study to Assess the Effect and Safety of TD-9855 in Subjects with Neurogenic Orthostatic Hypotension
This Study is in collaboration with Theravance Biopharma R & D They are testing the acute efficacy and safety of a new compound (TD-9855) in improving blood pressure and reducing orthostatic symptoms in patients that have neurogenic orthostatic hypotension (nOH), which includes those with MSA. This study is also open to patients with Pure Autonomic Failure (PAF) and Parkinson’s Disease (PD) with NOH.
Eligibility: 40 years and older, All Genders
Diagnosed with symptomatic orthostatic hypotension due to Parkinson’s disease, MSA or PAF (ie.neurogenic orthostatic hypotension)
At screening, a subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a > 30 mm Hg drop in systolic blood pressure (SBP) within 5 minutes of standing.
Impaired autonomic reflexes, as determined by the absence of BP overshoot during phase IV of the Valsalva maneuver, in subjects where Valsalva is performs as appropriate.
For the optional open-label extension study subjects must have demonstrated a pressor effect and completed dosing in Cohort 1.
Estimated completion date: June 2018 (Completed, results not yet published)
See study for further info and exclusions: https://clinicaltrials.gov/ct2/show/NCT02705755
NYU Information sheet: https://dysautonomiacenter.com/2017/04/10/two-new-studies-open-for-patients-with-msa/
STILL RECRUITING: Study 2: Norepinephrine Transporter Blockade, “Autonomic Failure”
This study is supported by The Food and Drug Administration’s Office of Orphan Product development. , We are testing whether we can repurpose an available drug (atomoxetine) as a treatment for neurogenic orthostatic hypotension (nOH). This study is also open to patients with MSA, pure autonomic failure (PAF), and Parkinson disease (PD) with OH.
Eligibility: 40 to 80 years old, any gender, with Neurogenic Orthostatic Hypotension (defined by a reduction of > 30 mmHg drop in SBP within 3 minutes of standing, associated with impaired autonomic reflexes as assessed by autonomic function tests.
See study for further info and exclusions: https://clinicaltrials.gov/ct2/show/NCT02784535
NYU Information sheet: https://dysautonomiacenter.com/2017/04/10/two-new-studies-open-for-patients-with-msa/
Recruiting: Vagal Stimulation in POTS - The Autonomic Inflammatory Reflex (Pilot 3)
The purpose of this study is to investigate how the electrical stimulation of a nerve in the skin of your earlobe (transcutaneous vagal nerve stimulation) affects the way your autonomic nervous system controls your heart rhythm.
Eligibility: Participants must be female between the ages of 18-45 diagnosed with POTS.
See Study for further information and exclusions: https://www.rarediseasesnetwork.org/cms/autonomic/6111
This study is a part of the Rare Disease Clinical Research Network and the Autonomic Disorders Consortium
Contact: Vanderbilt University Medical Center Nashville
Misty Hale CCRP, 615-322-2931, misty.hale@Vanderbilt.edu
Recruiting: The Big POTS Survey is still recruiting
This study’s lead investigator is Dr. Satish Raj MD MSCI, Adjunct Professor of Medicine at Vanderbilt University’s Autonomic Dysfunction Center. Dr. Rah says that the information collected as part of this survey “will help us learn more about the possible underlying causes and risk factors for developing POTS, treatments, and the economic, educational and social impact of POTS on patients and their families.” Dr. Raj serves on the Medical Advisory Board for DINET and Dysautonomia International. DI is sponsoring this survey.
Edited by edriscoll