Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096902
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-11-16
Brief Title:
Non-Pharmacologic Therapy for Neurocardiogenic Syncope
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Non-Pharmacologic Therapy for Neurocardiogenic Syncope
Status:
COMPLETED
Status Verified Date:
2006-09-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 persons 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 bodys 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 patients 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 patients body to help hold himher on the table Then the table will tilt the patient from a flat position to an upright one in about 10 seconds The patient will stay upright for 45 minutes while symptoms are monitored measurements are taken and blood samples are collected through the intravenous tube Then the table will be returned to the flat position If the patient faints or is about to faint or if he or she has an unsafe heart rhythm before the 45 minutes is over the test will be stopped and the table will be returned to the flat position Symptoms will be treated as needed
Patients who qualify for further study will then become familiar with hypnosis and be evaluated for their natural ability for experiencing it A professionally trained doctor will guide patients into a hypnotic state and patients will be asked to respond to various suggestions They will be videotaped an activity that will require a separate consent form Following these procedures patients will be assigned to one of the four groups in this study Those in the hypnosis group will have weekly sessions for 6 weeks with each session lasting about 1-12 hours The education group will meet a study investigator for learning about syncope and the autonomic nervous system with each session lasting about 1-12 hours once a week for 6 weeks The hand exercise group will be taught certain hand exercises to perform at home and as instructed for 6 weeks The diary group will receive instructions on keeping a diary pertaining to their condition at home for 6 weeks After 6 weeks patients will return for an evaluation to include completion of questionnaires and another tilt table test and blood collection by intravenous tube This entire study will take about 8 weeks There may be direct benefits from participating in this study The experimental procedures may help patients neurocardiogenic syncope
After completing this study patients will be offered any or all of the experimental procedures tested in this study upon their request and at the discretion of the principal investigator For example a patient who is assigned to the diary group may be offered hypnosis education and hand exercise instruction after completion of the study
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 bodys 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 patients 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 patients body to help hold himher on the table Then the table will tilt the patient from a flat position to an upright one in about 10 seconds The patient will stay upright for 45 minutes while symptoms are monitored measurements are taken and blood samples are collected through the intravenous tube Then the table will be returned to the flat position If the patient faints or is about to faint or if he or she has an unsafe heart rhythm before the 45 minutes is over the test will be stopped and the table will be returned to the flat position Symptoms will be treated as needed
Patients who qualify for further study will then become familiar with hypnosis and be evaluated for their natural ability for experiencing it A professionally trained doctor will guide patients into a hypnotic state and patients will be asked to respond to various suggestions They will be videotaped an activity that will require a separate consent form Following these procedures patients will be assigned to one of the four groups in this study Those in the hypnosis group will have weekly sessions for 6 weeks with each session lasting about 1-12 hours The education group will meet a study investigator for learning about syncope and the autonomic nervous system with each session lasting about 1-12 hours once a week for 6 weeks The hand exercise group will be taught certain hand exercises to perform at home and as instructed for 6 weeks The diary group will receive instructions on keeping a diary pertaining to their condition at home for 6 weeks After 6 weeks patients will return for an evaluation to include completion of questionnaires and another tilt table test and blood collection by intravenous tube This entire study will take about 8 weeks There may be direct benefits from participating in this study The experimental procedures may help patients neurocardiogenic syncope
After completing this study patients will be offered any or all of the experimental procedures tested in this study upon their request and at the discretion of the principal investigator For example a patient who is assigned to the diary group may be offered hypnosis education and hand exercise instruction after completion of the study
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 hypnosis patient education hand exercises and diary-keeping
Study Population Subjects are patients ages 18 years or older with recurrent neurocardiogenic syncope or presyncope
Design Patients who have a positive screening tilt table test are assigned to one of four groups hypnosis patient education hand exercises or diary-keeping Following 6 weeks of outpatient intervention all patients undergo repeat tilt table testing to complete the study
Outcome Measures The primary outcome measure is occurrence of syncope or presyncope during upright tilt table testing Secondary measures are hemodynamic and neurochemical parameters during upright tilt table testing and quality of life measures including recurrence of outpatient syncopal episodes
Study Population Subjects are patients ages 18 years or older with recurrent neurocardiogenic syncope or presyncope
Design Patients who have a positive screening tilt table test are assigned to one of four groups hypnosis patient education hand exercises or diary-keeping Following 6 weeks of outpatient intervention all patients undergo repeat tilt table testing to complete the study
Outcome Measures The primary outcome measure is occurrence of syncope or presyncope during upright tilt table testing Secondary measures are hemodynamic and neurochemical parameters during upright tilt table testing and quality of life measures including recurrence of outpatient syncopal episodes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0024 | None | None | None |