Autonomic Nervous System and Chronic Fatigue Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Chronic Fatigue SyndromeOrthostatic IntolerancePostural 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

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University

OTHER

NCT00580619 - Autonomic Nervous System and Chronic Fatigue Syndrome | Biotech Hunter | Biotech Hunter