Clinical trial: Non-Pharmacologic Therapy for Neurocardiogenic Syncope (NCT00096902)

Eligibility criteria:
-  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? 0