Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

NCT ID: NCT05618054

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2025-12-31

Brief Summary

This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.

Conditions

Postural Tachycardia Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Adolescents with POTS

Group Type: OTHER

Looming task

Intervention Type: BEHAVIORAL

Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear.

Adolescents without POTS

Group Type: OTHER

Looming task

Intervention Type: BEHAVIORAL

Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear.

Interventions

Looming task

Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Females 12-21 years old
• Able to communicate and provide consent/assent
• English speaking
• Diagnosed with POTS (POTS will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically)
• Age-matched healthy control subjects: no POTS or other neurological disorders

Exclusion Criteria

• Inflammatory arthritis, connective tissue or auto-immune disorder
• Any chronic neurological disorder besides POTS
• Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
• Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
• Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
• Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
• Current substance or alcohol abuse
• Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
• Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
• Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
• Chronic use of narcotics for pain
• Claustrophobia or any metal hardware that may interfere with MRI
• Investigators and study staff

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisela Chelimsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gisela Chelimsky, M.D.

Role: CONTACT

gisela.chelimsky@vcuhealth.org

(804) 628-0145

Madison Maxwell, B.S.

Role: CONTACT

madison.maxwell@vcuhealth.org

Other Identifiers

HM20025242

Identifier Type: -

Identifier Source: org_study_id