Clinical Autonomic Disorders: A Training Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT02154009
First received: May 31, 2014
Last updated: July 16, 2014
Last verified: May 2014
  Purpose

Background:

- The autonomic nervous system helps control things that happen automatically in the body, like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn how to better diagnose them.

Objectives:

  • To allow people with autonomic disorders to be evaluated.
  • To help fellows in the NIH Autonomic Disorders fellowship program see a variety of diseases in their training.

Eligibility:

  • People age 18 and older with dysautonomia; children over age 2 if they might benefit
  • Healthy adult volunteers

Design:

  • Participants will have different procedures depending on their symptoms. They will have one or more visits. They will have some but not all of the tests below.
  • Participants will have a medical history and physical exam. They may be tested for problems thinking. They may complete a symptom questionnaire. They may have their temperature and blood pressure taken.
  • Participants may have an intravenous line placed. A needle will guide a thin plastic tube into an arm vein.
  • Participants may have blood drawn several times. They may give a urine sample.
  • Participants may have an electrocardiogram.
  • How much blood a participant s heart is pumping and/or how much blood is flowing through their arm may be measured. The total amount of blood in their bloodstream may be measured.
  • Participants may have their ability to sweat and/or sense of smell tested.
  • Breathing, bowel sounds, and/or body functions may be monitored.
  • Pupil size, response to environmental temperature changes, and/or breathing may be measured.
  • Participants may have a bladder ultrasound.
  • Small pieces of skin may be taken for study.

Condition
Chronic Fatigue Syndrome
Pseudopheochromocytoma
Healthy Volunteers
Neurocardiogenic Syncope
Postural Tachycardia Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Autonomic Disorders: A Training Protocol

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Sucessful completion of the Clinical Fellowship in autonomic disorders [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVE:

This Protocol is to facilitate training of Fellows in evaluation of clinical disorders of the autonomic nervous system. The training is necessary to enable Fellows to sit for and pass the certifying examination in autonomic disorders administered by the United Council for Neurologic Subspecialties (UCNS) and to maintain UCNS accreditation of the Fellowship. A secondary objective is to include results of evaluations and testing with those from other Protocols, for future data analyses.

STUDY POPULATION:

Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system and healthy adult volunteers. Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function.

DESIGN:

Clinical physiologic, neuropharmacologic, and neurochemical testing will be performed during outpatient clinic visits or during inpatient admissions, depending on the individual testing schedule. Inpatient testing may be done in conjunction with other Protocols (e.g., 03-N-0004). Most of the testing under this Protocol can be completed in a single outpatient visit over the course of a workday. Testing procedures under this Protocol will be performed as needed for adequate Fellow training. In addition to autonomic medical history and physical examination, clinical testing procedures may include (A) monitoring of hemodynamics, sweating, and other physiologic parameters associated with the Valsalva maneuver, orthostasis, or external temperature manipulation; (B) venous blood sampling for assays of levels of catecholamines and related neurochemicals; (C) administration of autonomic test drugs; (D) skin biopsies; (E) blood volume measurement; (F) pupillometry; (G) gastrointestinal phonography; (H) urinary bladder ultrasound; and (I) neurobehavioral rating scales.

OUTCOME MEASURES:

The main outcome measure is competency in clinical and laboratory evaluation of autonomic disorders, based on assessment of the Fellow by the Principal Investigator at approximately 6-month intervals. A secondary outcome measure is results obtained under this Protocol, which may be analyzed and reported as research data along with data from other Protocols

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • PATIENTS

INCLUSION CRITERIA:

Patients may be included if they are at least 18 years old and are known or suspected to have failure of one or more components of the autonomic nervous system, small fiber neuropathy, inherited dysautonomia, orthostatic intolerance, neurocardiogenic syncope, status post

endoscopic thoracic sympathectomy, or disorders of catecholamine synthesis or fate.

Children greater than two years old may be enrolled in this Protocol if they might personally benefit from the tests in the Protocol through the establishment of a diagnosis.

EXCLUSION CRITERIA:

There are no exclusion criteria for the study as a whole.

HEALTHY VOLUNTEERS

INCLUSION CRITERIA:

Healthy adult Volunteers (at least 18 years old) may be included, pending normal or medically insignificant results of history and physical examination. A repeat history and physical examination is required if more than 6 months have gone by from a previous workup.

EXCLUSION CRITERIA:

A candidate Healthy Volunteer will be excluded if the person has any of the following: symptoms of autonomic dysfunction, including lightheadedness, fainting, abnormalities of sweating, frequent nausea, vomiting, constipation, or diarrhea, or urinary frequency or retention. If the Volunteer has a condition requiring medication that in the judgment of the Investigators will affect results of the pupillometric tests under this Protocol, the Volunteer may be included for training purposes.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02154009

Contacts
Contact: Janna Peries, R.N. (301) 435-5166 jperies@ninds.nih.gov
Contact: David S Goldstein, M.D. (301) 496-2103 goldsteind@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: David S Goldstein, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT02154009     History of Changes
Other Study ID Numbers: 140122, 14-N-0122
Study First Received: May 31, 2014
Last Updated: July 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Autonomic Nervous System
Catecholamines
Dysautonomia
Parasympathetic Cholinergic System
Sympathetic Adrenergic System

Additional relevant MeSH terms:
Orthostatic Intolerance
Autonomic Nervous System Diseases
Primary Dysautonomias
Fatigue
Fatigue Syndrome, Chronic
Syncope
Tachycardia
Syncope, Vasovagal
Postural Orthostatic Tachycardia Syndrome
Nervous System Diseases
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Neuromuscular Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014