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
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.
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