Postural Tachycardia Syndrome Clinical Trial
Official title:
Relationship of Autonomic Function to Hypnotic Susceptibility
This study will investigate the relationship between susceptibility to hypnosis and
regulation of the autonomic nervous system (nerves that control involuntary body functions,
such as heart rate and sweating).
Hypnosis is a state of mind in which the individual is highly focused, relatively unaware of
his or her surroundings, and possibly more able to accept and use therapeutic suggestions.
People vary in their responsiveness, or susceptibility, while in hypnosis. People with
certain conditions, such as chronic fatigue syndrome (CFS), chronic pain, posttraumatic
stress disorder (PTSD), and generalized anxiety disorder (GAD) have altered hypnotic
susceptibility. Patients with chronic orthostatic intolerance (COI) often have symptoms
similar to those of individuals with CFS, chronic pain, PTSD, and GAD, and this study will
examine how patients with COI respond to hypnosis as compared with healthy normal
volunteers. COI is a group of disorders characterized by intolerance to prolonged standing.
Among them are neurocardiogenic syncope (NCS), in which patients have recurrent episodes of
sudden loss of consciousness, and postural tachycardia syndrome (POTS), in which patients
have a sustained increase in heart rate after standing.
In addition to the comparison of COI and normal volunteer responses to hypnosis, the study
will examine how hypnotic susceptibility is related to the ability to control autonomic
functions such as blood pressure, heart rate, and sweating. The autonomic nervous system is
activated when the body is stressed, not only from physical stimuli such as cold
temperature, but also from mental stimuli, such as seeing a rattlesnake up close. Hypnosis
may, therefore, be a useful tool to understand how the mind controls the autonomic nervous
system.
Healthy normal volunteers and patients with NCS or POTS who are 18 years of age or older may
be eligible for this two-part study. In part 1, participants complete a questionnaire and
are then tested for hypnotic susceptibility. For this test, a professionally trained
physician guides the subject through a procedure to achieve a hypnotic state. The subject is
asked to perform several simple tasks and is then guided back to a normal state of being. In
part 2, the subject undergoes hypnosis again, during which the physician offers various
suggestions while monitoring activity of the subject's autonomic nervous system. The subject
is connected to various sensors that continuously monitor blood pressure, heart rate, blood
flow, sweat response, skin electrical conduction, and brain wave activity. An intravenous
catheter is inserted into an arm vein to collect blood samples. At the end, the subject is
guided back to a normal state of being.
The hypnosis session in part 1 is videotaped in order to: 1) permit review by a scientist
who is unaware of the subject's condition and whose judgment will not, therefore, be biased;
and 2) have a record of the experimental data. Only qualified investigators will view the
videotape.
This protocol describes a study to investigate the relationship between susceptibility to
hypnosis and regulation of the autonomic nervous system. Several studies have demonstrated
that individuals with particular conditions such as chronic fatigue syndrome (CFS),
posttraumatic stress disorder (PTSD), chronic pain, and generalized anxiety disorder (GAD),
have altered hypnotic susceptibility. Patients with chronic orthostatic intolerance (COI), a
general category of autonomic dysfunction that includes neurocardiogenic syncope (NCS) and
postural tachycardia syndrome (POTS), often present with symptoms that are similar to those
seen in CFS, PTSD, chronic pain, or GAD. These observations led to the hypothesis tested in
this protocol that patients with COI may also have altered hypnotic susceptibility. We also
hypothesize that increased hypnotic susceptibility will correlate with increased ability to
modulate autonomic function appropriately in response to suggestions during hypnosis.
The study population includes normal volunteers and patients with NCS or POTS. The design is
blinded and correlative. Primary outcome measures are hypnotic susceptibility as measured by
standardized scales; self-report inventory scores of psychobehavioral variables; physiologic
parameters such as hemodynamics, sweating, skin electrical conductance, body temperature,
respiratory rate, and bispectral analysis; and plasma catechol levels. The results of this
study may lead to novel therapeutic strategies using hypnosis for COI.
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