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NCT00096902 · ClinicalTrials.gov registry record · Phase 2
Non-Pharmacologic Therapy for Neurocardiogenic Syncope
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT00096902 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 45 participants.
The verdict
NCT00096902, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study 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. 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
Interventions
- PROCEDURE Tilt table test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2004-11-08 |
| Est. Completion | 2006-09-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00096902
The ClinicalTrials.gov registry entry for NCT00096902 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tilt table test is the first listed.
NCT00096902 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00096902 about?
NCT00096902 is a clinical study titled "Non-Pharmacologic Therapy for Neurocardiogenic Syncope". 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...
What is the current status of trial NCT00096902?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2004-11-08. Estimated completion is 2006-09-11.
What interventions are being tested in trial NCT00096902?
The interventions under investigation include: Tilt table test (PROCEDURE).
Who is sponsoring clinical trial NCT00096902?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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