Autonomic Nervous System and Chronic Fatigue Syndrome

Summary

The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).

Conditions

• Chronic Fatigue Syndrome
• Orthostatic Intolerance
• Postural Tachycardia Syndrome

Interventions

OTHER

Autonomic Function Testing

The autonomic function tests include asking the subject to breathe deeply for two minutes and breathing as fast and as hard as they can for 30 seconds, maintaining a handgrip for 3 minutes, breathing against pressure for 15 seconds, placing one hand in ice water for 1 minute and an orthostatic test. All these tests are meant to stimulate the autonomic nervous system to produce changes in blood pressure and heart rate of short duration that reflect how well the involuntary nervous system is working. In addition, a 24-hour blood pressure monitoring and exercise test may be also performed in some subjects.

OTHER

Saline infusions

The effects of continuous IV infusion or pulse IV administration of saline in increasing total blood volume and fatigue score will be evaluated

DRUG

L-NMMA trimethaphan

Trimethaphan IV infusion for approximately 60 minutes at a dose of 4-6 mg/min L-NMMA IV infusion for approximately 45 minutes at 125, 250, and 500 mg/kg/min for 15 minutes each

DRUG

methyldopa

Aldomet oral twice a day for 12 weeks

Sponsors & Collaborators

• Vanderbilt University

  lead OTHER

Principal Investigators

• Italo Biaggioni, MD · Vanderbilt University

Study Design

Allocation

NON_RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• United States

Study Locations