Status:
COMPLETED
Non-Pharmacologic Therapy for Neurocardiogenic Syncope
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Syncope
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. ...
Detailed Description
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 hy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 8 2004
Trial Type :
INTERVENTIONAL
End Date :
September 11 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00096902
Start Date
November 8 2004
End Date
September 11 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892