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New treatment option for Postural Tachycardia Syndrome
Official title Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
ClinicalTrials.gov ID: NCT05618054
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Age-matched healthy control people: no POTS or other neurological disorders
You likely can't join if
- 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...
- 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)
See the full eligibility 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 people: no POTS or other neurological disorders
- 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...
- 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...
- Chronic use of narcotics for pain
- Claustrophobia or any metal hardware that may interfere with MRI
- Investigators and study staff
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 12 years to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.