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Protocol Details

Clinical Autonomic Disorders: A Training Protocol

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-N-0122

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

Tyramine
Acetylcholine

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

None

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.

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Eligibility

INCLUSION CRITERIA - PATIENTS:

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 - PATIENTS:

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

INCLUSION CRITERIA - HEALTHY VOLUNTEERS:

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 - HEALTHY VOLUNTEERS:

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

David S. Goldstein, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 5N220
10 CENTER DR
BETHESDA MD 20814
(301) 496-2103
goldsteind@ninds.nih.gov

Janna Gelsomino, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5653
10 Center Drive
Bethesda, Maryland 20892
(301) 435-5166
janna.gelsomino@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02154009

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