fMRI in Postural Tachycardia Syndrome

Postural Tachycardia Syndrome Clinical Trial

— POTS  

Official title:

Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137757
• Other study ID #: Study00012860
• Secondary ID: UL1TR002014
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Aimee J Cauffman, RN
• Phone: 717-531-1617
• Email: acauffman[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postural tachycardia syndrome (POTS) is one of the most common forms of chronic orthostatic intolerance in the United States. This is a disabling disorder characterized by an excessive increase in heart rate upon standing that is accompanied by symptoms such as dizziness and fatigue. One of the most under appreciated and bothersome symptoms of POTS is impaired cognition or "brain fog," which occurs to a level that interferes with daily activities such as work and education. Despite this high impact, the reasons why POTS patients have problems with cognition are not well understood. This project will test the overall hypothesis that "brain fog" in POTS is related to increased activation of cognitive brain regions during mental tasks when compared with healthy subjects, and that this activation is exacerbated by in the presence of orthostatic stress.

Description:

A randomized, double blind, crossover study will be conducted to determine if there are differences in resting brain structure and blood oxygen perfusion in postural tachycardia syndrome (POTS) compared with healthy subjects, and to identify the pattern of brain activation produced by cognitive testing under resting conditions and in the presence of a physical challenge mimicking orthostatic stress (lower body negative pressure, LBNP). This is an outpatient study that requires a screening visit in the Clinical Research Center within the Penn State Hershey Medical Center, and if eligible, two study visits in the Penn State Center for Nuclear Magnetic Resonance Imaging involving blood oxygen level dependent functional magnetic resonance imaging (BOLD-fMRI) and a cognitive test while lying in a magnetic resonance imaging (MRI) scanner with the lower body placed in the LBNP chamber. The LBNP chamber applies suction to the lower body to pool blood in the legs and physiologically mimic what happens when standing up. Blood pressure, heart rate, and oxygen saturation will be measured throughout the study. A scan will be performed while at rest to look at the structure and blood oxygen perfusion in the brain. The LBNP or sham pressure will then be initiated, with the order determined randomly and the other stress applied at the second study visit. Once the appropriate level of pressure is achieved, brain oxygen perfusion will be measured and subjects will be asked to complete one test of cognitive function. At the end of the cognitive test, brain oxygen levels will be measured and the testing will end. The time inside the MRI scanner at each study visit will be approximately 45 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Men and women of all races

• 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).

• 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

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Other:
• Lower Body Negative Pressure
Lower body negative pressure will be applied.
• Sham Pressure
Noise will be turned on but no pressure will be applied.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Brain Region Activation	The change in activation of cognitive brain regions measured by blood oxygen dependent functional magnetic resonance imaging following cognitive tasks and orthostatic stress.	60 minutes
Secondary	Brain Oxygen Perfusion	The change in brain oxygen perfusion measured by arterial spin labeling magnetic resonance imaging following cognitive tasks and orthostatic stress.	60 minutes
Secondary	Blood Pressure	The change in blood pressure following cognitive tasks and orthostatic stress.	60 minutes
Secondary	Heart Rate	The change in heart rate following cognitive tasks and orthostatic stress.	60 minutes
Secondary	Stroop Word-Color Score	The change in the Stroop word-color test score following orthostatic stress and sham stress. This test measure executive function. The scores are T-scores normalized to population averages based on age and education level from 0 to 100. A higher score indicates better executive function.	10 minutes