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Evaluation of Primary Chronic Autonomic Failure

NCT00059033 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 325

Last updated 2019-12-12

No results posted yet for this study

Summary

This study will conduct tests in patients with primary chronic autonomic failure (CAF) to learn more about these disorders, which include pure autonomic failure, multiple system atrophy, Parkinson's disease with autonomic failure, and autoimmune autonomic neuropathy.

Healthy volunteers and patients with primary CAF 18 years of age or older may be eligible for this study. Participants undergo some of the following tests:

* Blood studies, including arterial catheter insertion to measure blood pressure and collect arterial blood samples, blood flow studies using sensors applied to the skin and a pressure cuff around a limb, and blood draw for genetic studies.
* Bladder motility: Ultrasound test of bladder function.
* Electrocardiogram and heart ultrasound.
* Responses to changes in temperature: Warm water and then room temperature water are passed through watertight pads applied to the back and front of the body and body temperatures are measured.
* Gastrointestinal motility: Bowel sounds are recorded using a microphone placed on the abdomen.
* Lower body negative pressure: The lower body is placed into an airtight barrel-like chamber. Some air is sucked out of the barrel, causing blood to pool in the legs, as occurs during standing.
* Lumbar puncture: A needle is inserted in the space between the bones in the lower back to collect a small sample of cerebrospinal fluid.
* Microdialysis to measures levels of chemicals in the body fluid of certain tissues. A solution is passed through a thin tube inserted into the skin. Chemicals in the body tissues enter the solution. The solution is collected and the chemical levels are measured.
* PET scanning: A nuclear medicine test to produce images of body organs. For patients with urinary problems, a catheter is inserted into the bladder before starting the scan.
* Pupillometry: The pupil of the eye is measured using a special camera in a light-controlled room.
* QSART. A small amount of a brain chemical is applied to the skin with a tiny amount of electricity, and the sweat in a nearby patch of skin is measured.
* Measurement of saliva production, using a cotton-like material placed between the teeth and gums to absorb saliva.
* Skin electrical conduction test, using sensors on the skin to measure sweat production.
* Skin and core temperature measurements using sensors on the skin and in the ear canal.
* Speech and swallowing assessment for patients with speech and swallowing difficulties.
* Stress echocardiogram: A catheter is placed in the subject's arm for sampling blood or giving a drug while the subject exercises. During the test, blood pressure, pulse rate, and EKG are continuously monitored.

Conditions

  • Autonomic Nervous System Diseases

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • David S Goldstein, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-10
Completion
2018-10-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00059033 on ClinicalTrials.gov