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Hypnosis in Autonomic Function

Primary Purpose

Vasovagal Syncope, Postural Tachycardia Syndrome, Hypnosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Vasovagal Syncope focused on measuring Chronic Orthostatic Intolerance, Dysautonomia, Postural Tachycardia Syndrome, Neurocardiogenic, Syncope, Neurocardiogenic Syncope, COI, POTS, Neurocardogenic Syncope, NCS, Healthy Volunteer, HV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Subjects are patients with COI (POTS or NCS) identified in existing diagnostic protocols of the Clinical Neurocardiology Section (CNCS) and age- and gender-matched healthy volunteers. Patients with COI must be evaluated first through these diagnostic protocols prior to being offered enrollment in this protocol. Participation in this protocol is offered to subjects independently of gender, race, ethnicity, religion, or creed. The studies in this protocol can be performed on an outpatient basis. Inpatients may also participate as long as participation does not interfere with the protocol(s) under which they have been admitted. EXCLUSION CRITERIA: Subjects are excluded based on: age less than 18 years, unwillingness to be hypnotized or videotaped; religious or other beliefs that would prevent engagement in hypnosis; psychosis or psychotic depression; non-fluency in spoken English; and inability to participate adequately in the tasks of the hypnotic susceptibility scale. In addition, patients are excluded if they are being treated with, and cannot discontinue, a drug likely to interfere with the scientific results. An example would be treatment with a beta-adrenoceptor blocker. Patients unable to discontinue nicotine or alcohol temporarily are excluded. Patients are not to discontinue any medications before the patient or the patient's doctor discusses this with the Principal Investigator, or the Research Nurse. If it is decided that discontinuing medications would be unsafe, then the patient is excluded from the study. Finally, subjects are excluded if there are technical limitations in placing an i.v. or monitoring devices.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 19, 2003
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00061009
Brief Title
Hypnosis in Autonomic Function
Official Title
Relationship of Autonomic Function to Hypnotic Susceptibility
Study Type
Observational

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasovagal Syncope, Postural Tachycardia Syndrome, Hypnosis
Keywords
Chronic Orthostatic Intolerance, Dysautonomia, Postural Tachycardia Syndrome, Neurocardiogenic, Syncope, Neurocardiogenic Syncope, COI, POTS, Neurocardogenic Syncope, NCS, Healthy Volunteer, HV

7. Study Design

Enrollment
93 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Subjects are patients with COI (POTS or NCS) identified in existing diagnostic protocols of the Clinical Neurocardiology Section (CNCS) and age- and gender-matched healthy volunteers. Patients with COI must be evaluated first through these diagnostic protocols prior to being offered enrollment in this protocol. Participation in this protocol is offered to subjects independently of gender, race, ethnicity, religion, or creed. The studies in this protocol can be performed on an outpatient basis. Inpatients may also participate as long as participation does not interfere with the protocol(s) under which they have been admitted. EXCLUSION CRITERIA: Subjects are excluded based on: age less than 18 years, unwillingness to be hypnotized or videotaped; religious or other beliefs that would prevent engagement in hypnosis; psychosis or psychotic depression; non-fluency in spoken English; and inability to participate adequately in the tasks of the hypnotic susceptibility scale. In addition, patients are excluded if they are being treated with, and cannot discontinue, a drug likely to interfere with the scientific results. An example would be treatment with a beta-adrenoceptor blocker. Patients unable to discontinue nicotine or alcohol temporarily are excluded. Patients are not to discontinue any medications before the patient or the patient's doctor discusses this with the Principal Investigator, or the Research Nurse. If it is decided that discontinuing medications would be unsafe, then the patient is excluded from the study. Finally, subjects are excluded if there are technical limitations in placing an i.v. or monitoring devices.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12416949
Citation
Goldstein DS, Robertson D, Esler M, Straus SE, Eisenhofer G. Dysautonomias: clinical disorders of the autonomic nervous system. Ann Intern Med. 2002 Nov 5;137(9):753-63. doi: 10.7326/0003-4819-137-9-200211050-00011.
Results Reference
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PubMed Identifier
12505571
Citation
Goldstein DS, Holmes C, Frank SM, Naqibuddin M, Dendi R, Snader S, Calkins H. Sympathoadrenal imbalance before neurocardiogenic syncope. Am J Cardiol. 2003 Jan 1;91(1):53-8. doi: 10.1016/s0002-9149(02)02997-1.
Results Reference
background
PubMed Identifier
11514377
Citation
Accurso V, Winnicki M, Shamsuzzaman AS, Wenzel A, Johnson AK, Somers VK. Predisposition to vasovagal syncope in subjects with blood/injury phobia. Circulation. 2001 Aug 21;104(8):903-7. doi: 10.1161/hc3301.094910.
Results Reference
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Hypnosis in Autonomic Function

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