EEG Characteristics in Youth POTS and/or Syncope
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|ClinicalTrials.gov Identifier: NCT02167412|
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : March 27, 2018
|Condition or disease|
|Syncope Postural Tachycardia Syndrome Orthostatic Intolerance|
All POTS and syncope patients referred to Nationwide Children's Hospital (Columbus, OH) and meeting study eligibility criteria will be asked to participate. Consent and assent will be obtained per IRB guidelines. Consenting patients will undergo head-upright tilt (HUT) testing with video EEG and continuous sweat monitoring.
Prior to testing all medicines that can affect orthostatic tolerance will be held a minimum of 5 half-lives. Caffeine will be held for a minimum of 24 hours. Urinalysis (for urine specific gravity) and pregnancy testing (for female patients of child-bearing age) will be done the day of HUT testing. A recumbent EEG sample of no less than 10 minutes will be obtained. EKG leads, Holter leads, blood pressure monitors (beat-to-beat and conventional arm cuff), intravenous (IV) line, and sweat monitors will be placed. Sweat rate, EEG, and blood pressure monitoring will be synchronized by event trigger, allowing co-registration of all timed studies during data post-processing. Serum norepinephrine levels will be obtained at the time of IV placement and at 10 minutes of tilt or during/immediately after the syncope prodrome if syncope occurs prior to 10 minutes.
Once all monitors are placed, 10 minutes of EEG have been collected, and the patient has been recumbent for a minimum of 30 minutes, the table is tilted up-right to 70 degrees. A video camera will be on during the test. Patients are encouraged to report all symptoms and they are frequently examined for signs of pallor, acrocyanosis and sweating. Tilt testing is continued until syncope occurs, up to 10 minutes if the patient meets POTS criteria, or up to 45 minutes if neither syncope or POTS is not present.
Those who do meet age-appropriate POTS criteria (symptomatic heart-rate increment >40 bpm or symptomatic total HR of >130 bpm, all within 10 minutes of tilt for those <20 years of age) will be lowered at 10 minutes (or sooner with syncope) and asked to repeat testing with abdominal and lower extremity compression. The compression suit has been used by Dr. Heyer in other NCH studies. It is composed of a Neoprene-like material with 5 Velcro straps that fit snugly around the legs, thighs and abdomen. The abdominal strap contains an air-filled bladder that potentiates abdominal compression. We have used the suit in over 30 consenting patients from prior study. None of the study participants complained of discomfort. The suit successfully reduced both heart rate and orthostatic symptoms in youth with POTS; 55% of studied patients no longer met POTS diagnostic criteria while the suit was on (see PMID: 24840763 for manuscript). We will use the compression suit as our method of attenuating POTS symptoms during HUT testing. EEG will be compared without and with compression.
The time frame for this study is on average 90 minutes. It will not exceed 3 hours. After lowering the tilt table, all monitor leads and the IV will be removed. Once leads are removed there are no further study obligations.
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Electroencephalographic (EEG) Characteristics of Postural Tachycardia Syndrome (POTS) and Syncope (Without POTS) During Head-upright Tilt Table Testing|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||May 2016|
Syncope without POTS
Patients meeting syncope criteria without POTS. There will be no intervention for this study arm.
- Video EEG characteristics of POTS and syncope [ Time Frame: The time frame on average is 90 minutes and will not exceed 3 hours. ]Video EEG characteristics of orthostatic intolerance symptoms related to POTS (with and without syncope) and to syncope (without POTS) will be identified and compared between POTS and syncope cohorts.
- EEG characteristics of POTS with and without compression [ Time Frame: The time frame on average is 90 minutes and will not exceed 3 hours. ]POTS patients will undergo two separate HUT tests, without and with abdominal and lower extremity compression. EEG characteristics will be compared between trials.
- EEG comparison of syncopal prodrome with and without POTS [ Time Frame: The time frame on average is 90 minutes and will not exceed 3 hours. ]EEG changes that correspond with the pre-syncopal prodrome (e.g., electrographic slowing) will be compared in terms of duration, quality of onset, and degree of change between syncope patients with and without POTS.
- Correlation between sweat rate and EEG changes [ Time Frame: The time frame on average is 90 minutes and will not exceed 3 hours. ]Orthostatic intolerance often has associated increases in sweat production. We will compare sweat rate and EEG changes in terms of temporal onset and peak changes to determine if sweat production correlates with EEG slowing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167412
|United States, Ohio|
|Nationwide Children's Hopsital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Geoffrey L Heyer, MD||Nationwide Children's Hospital|