Non-Pharmacologic Therapy for Neurocardiogenic Syncope
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|ClinicalTrials.gov Identifier: NCT00096902|
Recruitment Status : Completed
First Posted : November 17, 2004
Last Update Posted : July 2, 2017
This study will examine whether certain procedures that do not involve the use of medications can reduce symptoms of neurocardiogenic syncope (SIN-ku-pe), or a condition involving recurrent fainting. This condition is also known as vasovagal syncope or neurally mediated hypotension. Neurocardiogenic syncope is a disorder of the autonomic nervous system, which controls automatic body functions such as blood pressure, heart rate, and sweating. That system can be affected by medications, conditions of the mind or body, and by a person's surroundings. Researchers in this study wish to learn whether hypnosis, hand exercises, education, or diary keeping can affect the autonomic nervous system and improve symptoms of neurocardiogenic syncope.
Patients age 18 or older who have neurocardiogenic syncope may be eligible for this study. Those who have a medical illness making it unsafe to participate, who cannot discontinue certain medications, or who are pregnant are not eligible. Patients will undergo a medical history and physical examination, complete a questionnaire, and experience Valsalva and tilt table tests. These tests will take about 5 hours during 1 to 2 days.
The Valsalva test evaluates some of the reflexes of autonomic nervous system. Patients will lie flat on a padded table and have sensors placed on the body, to measure blood pressure, breathing rate, and other functions. They will blow into a sterile tube for 12 seconds while the body's responses are measured. The procedure may need to be repeated several times. During the test, an intravenous tube, guided by a needle, will be placed in the patient's arm. The tube will be used to collect samples of blood (less than 7 tablespoons) to measure chemicals such as adrenaline. For the tilt table test, a patient will lie on a padded, motorized table and have sensors placed on the body. Velcro straps will be placed around the patient's body to help hold him/her on the table. Then the table will tilt the patient from a flat position to an upright one in about 10 seconds. The patient will stay upright for 45 minutes while symptoms are monitored, measurements are taken, and blood samples are collected through the intravenous tube. Then the table will be returned to the flat position. If the patient faints or is about to faint, or if he or she has an unsafe heart rhythm before the 45 minutes is over, the test will be stopped and the table will be returned to the flat position. Symptoms will be treated as needed.
Patients who qualify for further study will then become familiar with hypnosis and be evaluated for their natural ability for experiencing it. A professionally trained doctor will guide patients into a hypnotic state, and patients will be asked to respond to various suggestions. They will be videotaped, an activity that will require a separate consent form. Following these procedures, patients will be assigned to one of the four groups in this study. Those in the hypnosis group will have weekly sessions for 6 weeks, with each session lasting about 1-1/2 hours. The education group will meet a study investigator for learning about syncope and the autonomic nervous system, with each session lasting about 1-1/2 hours once a week for 6 weeks. The hand exercise group will be taught certain hand exercises to perform, at home and as instructed, for 6 weeks. The diary group will receive instructions on keeping a diary pertaining to their condition, at home, for 6 weeks. After 6 weeks, patients will return for an evaluation to include completion of questionnaires and another tilt table test and blood collection by intravenous tube. This entire study will take about 8 weeks. There may be direct benefits from participating in this study. The experimental procedures may help patients' neurocardiogenic syncope.
After completing this study, patients will be offered any or all of the experimental procedures tested in this study upon their request and at the discretion of the principal investigator. For example, a patient who is assigned to the diary group may be offered hypnosis, education, and hand exercise instruction after completion of the study.
|Condition or disease||Intervention/treatment||Phase|
|Syncope||Procedure: Tilt table test||Phase 2|
Objective: The objective of this protocol is to test the efficacy of non-pharmacologic interventions for recurrent neurocardiogenic syncope. Specifically, the interventions tested in this study are hypnosis, patient education, hand exercises, and diary-keeping.
Study Population: Subjects are patients ages 18 years or older with recurrent neurocardiogenic syncope or presyncope.
Design: Patients who have a positive screening tilt table test are assigned to one of four groups: hypnosis, patient education, hand exercises, or diary-keeping. Following 6 weeks of outpatient intervention, all patients undergo repeat tilt table testing to complete the study.
Outcome Measures: The primary outcome measure is occurrence of syncope or presyncope during upright tilt table testing. Secondary measures are hemodynamic and neurochemical parameters during upright tilt table testing, and quality of life measures including recurrence of outpatient syncopal episodes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Official Title:||Non-Pharmacologic Therapy for Neurocardiogenic Syncope|
|Study Start Date :||November 8, 2004|
|Estimated Study Completion Date :||September 11, 2006|
- Occurrence of syncope or presyncope during upright tilt table testing.
- Hemodynamic and neurochemical parameters during upright tile table testing, and quality of life measures including recurrence of outpatient syncopal episodes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096902
|United States, Maryland|
|National Institute of Neurological Disorders and Stroke (NINDS)|
|Bethesda, Maryland, United States, 20892|