Clinical Autonomic Disorders: A Training Protocol

NCT02154009 | Terminated

• 2 other identifiers: 14012214-N-0122
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Pseudopheochromocytoma; Healthy Volunteers; Neurocardiogenic Syncope; Postural Tachycardia Syndrome

Keywords

Autonomic Nervous System; Catecholamines; Dysautonomia; Sympathetic Cholinergic System; Sympathetic Adrenergic System

Outcome Measures

Primary Outcomes (1)

• Successful completion of the Clinical Fellowship in autonomic disorders

  Competency in clinical and laboratory evaluation of autonomic disorders, based on assessment of the Fellow by the Principal Investigator at approximately 6-month intervals

  approximately 6-month intervals.

Secondary Outcomes (1)

• Clinical samples and data from evaluation of patients with known or suspected autonomic disorders

  Initial Visit

Study Arms (2)

Healthy Volunteers

Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function.

Patients

Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, skin biopsy

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Syncope, Vasovagal; Postural Orthostatic Tachycardia Syndrome; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Orthostatic Intolerance; Primary Dysautonomias; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David S Goldstein, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2014
• First Posted: June 3, 2014
• Study Start: June 5, 2014
• Primary Completion: August 15, 2019
• Study Completion: April 7, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)