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Official Study Title: Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Laboratory Evaluation of Primary Chronic Autonomic Failure
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID:
Study ID: 030004; 03-N-0004

Summary

This study will conduct tests in people with primary chronic autonomic failure (CAF) to learn more about these disorders, which include pure autonomic failure (malfunction of the autonomic nervous system)  Autonomic Nervous SystemControls automatic functions, such as heartbeat, digestion, salivation, and blood pressure. , multiple system atrophy, Parkinson's disease with autonomic failure, and autoimmune autonomic neuropathy. Healthy volunteers and people 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 catheter insertion into artieries to measure blood pressure and collect blood samples, blood flow studies using sensors applied to the skin and a pressure cuff around a limb, and blood draw for genetic  GeneticReferring to a condition that is caused by a person's genes (heredity). studies. - Bladder motility: Ultrasound  UltrasoundAn imaging technique that creates images of areas inside the body using sound waves. 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 measure 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 people 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 people with speech and swallowing difficulties. - Stress echocardiogram: A catheter is placed in the people arm  ArmAny of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more. for sampling blood or giving a drug while the person exercises. During the test, blood pressure, pulse rate, and EKG are continuously monitored.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Contact trial organizers

Eligibility

• Minimum Age: 18
• Gender(s) Accepted: Either

Inclusion Criteria

• Participation in this study is offered to people 18 years old or older, independently of gender, race, age, ethnicity, religion, or any other demographic or sociopolitical classifications.
• People with known or suspected primary CAF, based on referral information and confirmation of the clinical diagnosis at the intake evaluation.
• Control participants previously diagnosed with PD or MSA without orthostatic hypotension (a temporary lowering of blood pressure due usually to suddenly standing up) as confirmed at the time of the intake evaluation.

Exclusion Criteria

• People younger than 18 years old, however, advanced age does not constitute an exclusion criterion.
• People for whom study participation poses a substantially increased acute medical risk. This includes the risks associated with air travel to the NIH.
• People with a disqualifying condition, such as hepatic or renal failure, congestive heart failure, severe anemia, psychosis,  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. refractory ventricular arrhythmias, and heart disease. Positive HIV status is not necessarily a disqualifying condition.
• People whose intake evaluation results lead to a diagnosis of a secondary form of CAF, such diabetic autonomic neuropathy.
• People with a history of glaucoma will have an ophthalmology consult to determine if exposure to any of the procedures or test drugs would place the person at undue risk. If so, then the person will be excluded from the study.
• People required to continue treatment with a drug likely to interfere with the scientific results.
• People with known or suspected allergy or hypersensitivity to any test drug are excluded from receiving that drug.
• People who must take medications daily in the following categories: anticoagulants, tricyclic antidepressants, barbiturates, aspirin, or acetaminophen.
• People who are unable to discontinue nicotine or alcohol use temporarily.
• Herbal medicines or dietary supplements that are known or suspected to interfere with the experimental results must be discontinued before enrollment in the study. Some exceptions may be made.
• People in whom the investigators feel it would be difficult to insert a catheter into a vein.
• People who are not expected clinically to tolerate lying still during the procedures.
• Pregnant or lactating women.

Enrollment

Expected Enrollment: 205 (US)
Date Enrollment Began: Apr 01 2003
Last Updated Date: Jul 12 2007
Trial Post Date: Jul 12 2007
Website: http://clinicaltrials.gov/ct/show/NCT00059033?order=1

Primary Contacts and Locations

Maryland

• Patient Recruitment and Public Liaison Office
  National Institutes of Health  National Institutes of Health (NIH)The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Headquartered in Bethesda Maryland, it is composed of 27 Institutes and Centers and provides leadership and financial support to researchers in every state and throughout the world. Internet address: http://www.nih.gov. Clinical Center
  prpl@mail.cc.nih.gov
  Phone: (800) 411-1222
  9000 Rockville Pike
  Bethesda, MD 20892
  USA