Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT04137757
Eligibility Criteria:
Inclusion Criteria:
* Men and women of all races or ethnicity
* Age 18-60
* Healthy volunteers or previously diagnosed with POTS by current consensus criteria (rise in heart rate of at least 30 beats/minute within 10 minutes of standing; absence of orthostatic hypotension defined as a drop in blood pressure greater than 20/10 mmHg within 3 minutes of standing; and presence of daily orthostatic symptoms for at least 6 months such as lightheadedness, dizziness, nausea, and palpitations).
* Healthy participants must have cognitive testing scores within normal range (defined by Stroop word-color test score between 40-70) and be able to tolerate lower body negative pressure.
* POTS participants must have either mild cognitive dysfunction (defined by Stroop word-color t-score \<40 and \>30) or normal cognitive function (defined by Stroop word-color test score between 40-70), and able to tolerate lower body negative pressure.
* Capable of giving informed consent
* Fluent in written and spoken English
Exclusion Criteria:
* Age \<18 years or \>60 years
* Pregnant or breastfeeding women
* Left handedness
* Require glasses for vision correction (contact lenses are okay)
* Current smokers
* Alcohol or drug abuse
* Recreational drug use (e.g. cannabis, heroin, cocaine)
* Other potential causes for tachycardia (e.g. prolonged bed rest, dehydration)
* Taking selective norepinephrine reuptake inhibitors or stimulant medications within the past 3 months as these may alter cognition
* Unable to tolerate an MRI scanner (e.g. claustrophobia, implanted metal)
* Unable to give or withdraw informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04137757
Study Brief:
Protocol Section:
NCT04137757