Non-Pharmacologic Therapy for Neurocardiogenic Syncope
Non-Pharmacologic Therapy for Neurocardiogenic Syncope
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.
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.
-  INCLUSION CRITERIA:

 Subjects are patients referred for neurocardiogenic syncope or presyncope, with or without
 postural tachycardia syndrome (POTS). Patients enter the trial after positive tilt table
 testing during the screening evaluation. Participation is offered to individuals 18 years
 old or older, independently of gender, race, advanced age, ethnicity, religion, or any
 other demographic or sociopolitical classifications.

 EXCLUSION CRITERIA:

 Minors younger than 18 years old are excluded. Advanced age is not an exclusion criterion.

 Patients who have certain illnesses that would interfere or be contraindicated with the
 interventions or procedures in this study are excluded. These include significant coronary
 artery disease, psychosis, or psychotic depression.

 A candidate is excluded if the subject is unwilling to experience hypnosis or to have
 hypnosis sessions recorded; holds religious or other beliefs that would prevent engagement
 in hypnosis; is not fluent in spoken English; or has physical or other disabilities that
 prevent adequate participation in hypnotic susceptibility testing.

 Certain herbal medicines or dietary supplements are known or suspected to interfere with
 the experimental results, and such herbal medicines or dietary supplements must be
 discontinued before enrollment in the study. For many herbal medicines or dietary
 supplements, the mechanisms of action and therefore the possible effects on the
 experimental results are unknown. In cases where the subjects wish to continue their herbal
 medicines or dietary supplements while on study, and search of the available medical
 literature fails to identify effects that are known or expected to interfere with the
 experimental results, then the subjects may participate.

 A candidate is excluded if clinical considerations require that the patient continue
 treatment with a drug likely to interfere with the scientific results. Patients who cannot
 discontinue medications in the following categories are excluded: certain
 anti-hypertensives including beta-blockers, anticoagulants, tricyclic antidepressants,
 barbiturates, and acetaminophen. Patients unable to discontinue nicotine, caffeine, or
 alcohol for 24 hours prior to tilt table testing are excluded. Patients with chronic
 alcohol intake are excluded. Patients are not to discontinue any medications before the
 patient or the patient's doctor discusses this with the Principal Investigator, Accountable
 Investigator, an Associate Investigator, or Research Nurse. If it is decided that
 discontinuing medications would be unsafe, then the patient is excluded.

 Patients who pose technical difficulties regarding the testing procedures are excluded.

 A candidate is excluded if, in the judgment of the Principal Investigator, Accountable
 Investigator, or Clinical Director, protocol participation would place the subject at
 substantially increased acute medical risk, or if the medical risk outweighs the potential
 scientific benefit.