Looming task for Postural Orthostatic Tachycardia Syndrome

Overseen By Madison Maxwell, B.S.

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Narcotics, Hormones, others

Disqualifiers: Arthritis, Neuropathy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how people with Postural Orthostatic Tachycardia Syndrome (POTS) perceive visual information. Researchers seek to learn more about how different parts of the brain communicate in individuals with and without POTS. Participants will engage in a task designed to study this visual processing, known as the "Looming task." Girls and young women, aged 12-21, who have been diagnosed with POTS or are healthy without neurological disorders, might be a good fit for this study. As an unphased study, this trial offers participants the opportunity to contribute to groundbreaking research that could enhance understanding of POTS and visual processing.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using hormones (except insulin, thyroid replacement, or oral contraceptives) or if you have been treated with an unapproved drug or medical device in the last 30 days.

What prior data suggests that the looming task is safe for adolescents?

Research has shown that Postural Orthostatic Tachycardia Syndrome (POTS) is a long-term condition that rarely causes death. Many individuals with POTS tend to improve over time. However, the safety of the "looming task" treatment remains unclear from the available sources. As the study is in an early phase labeled "Not Applicable," there may be limited evidence regarding its safety. Early trials typically focus on understanding how treatments work and may lack detailed safety information. Discuss any concerns with the study team or a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the looming task technique for Postural Orthostatic Tachycardia Syndrome (POTS) because it offers a novel approach to understanding and potentially managing this condition. Unlike traditional treatments that often rely on medications like beta-blockers or lifestyle modifications, this method focuses on the psychological aspect of POTS. The looming task involves cognitive exercises that might help retrain the brain's response to stressors, which could be a game-changer for adolescents dealing with POTS. By exploring how these cognitive tasks influence symptoms, researchers hope to uncover new pathways for intervention that could complement existing therapies.

What evidence suggests that the looming task is effective for Postural Orthostatic Tachycardia Syndrome?

Direct evidence on the effectiveness of the "looming task" for treating Postural Orthostatic Tachycardia Syndrome (POTS) is limited, as it is not a common treatment. POTS causes an increased heart rate upon standing, leading to dizziness and other symptoms. This trial involves two groups: adolescents with POTS and those without. The researchers examine how individuals with POTS perceive and process visual information, which could enhance understanding of their brain function. Although this study does not directly test a treatment, its findings might eventually lead to new ways to manage or better understand POTS. ^{1 2 3 6 7}

Who Is on the Research Team?

Gisela Chelimsky, M.D.

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for females aged 12-21 with Postural Tachycardia Syndrome (POTS), who can communicate in English and give consent. Healthy girls without POTS or neurological disorders are also needed as controls. Participants should not be using certain hormones, have substance abuse issues, inflammatory/auto-immune diseases, unstable medical conditions like severe kidney/liver disease, uncontrolled psychiatric illnesses, or recent involvement in other drug/device trials.

Inclusion Criteria

English speaking

I am a female between the ages of 12 and 21.

I can understand and agree to the study's requirements.

Exclusion Criteria

You are claustrophobic or have metal inside your body that could cause problems during an MRI.

Investigators and study staff

I haven't used unapproved drugs or devices in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task and while at rest

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Looming task

Trial Overview The study tests how young women with POTS process visual information ('Looming task') to understand brain communication patterns. It aims to shed light on the condition's natural history and associated problems by comparing their responses to those of healthy individuals.

How Is the Trial Designed?

Group I: Adolescents without POTS Experimental Treatment 1 Intervention

Group II: Adolescents with POTS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

In a study of 246 patients with orthostatic intolerance symptoms, 40 were diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS), highlighting its prevalence and the need for awareness in young patients.

Common symptoms of POTS included loss of consciousness (77.5%), lightheadedness (75%), and palpitations (67.5%), with 45% of patients also experiencing neurocardiogenic syncope, indicating a significant impact on their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome in patients of orthostatic intolerance symptoms: an ambispective study. Chouksey, D., Rathi, P., Sodani, A., et al.[2022]

POTS is a significant autonomic disorder characterized by symptoms like light-headedness and palpitations, affecting young individuals, with a mean age of 24.9 years and a symptom duration averaging 70.7 months.

In a study of 16 patients, only five were functioning normally after an average follow-up of 8.9 months, highlighting the persistent nature of POTS and the need for better recognition and management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome: an underrecognized disorder. Pandian, JD., Dalton, K., Henderson, RD., et al.[2007]

Postural orthostatic tachycardia syndrome (POTS) is characterized by a significant increase in heart rate (≥30 bpm or >120 bpm) when standing, along with symptoms like dizziness and fatigue, indicating a problem with the autonomic nervous system.

Management of POTS involves both lifestyle changes and medications aimed at controlling heart rate, increasing blood volume, and reducing stress, highlighting the importance of a comprehensive treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postural orthostatic tachycardia syndrome]. Brinth, LS., Pors, K., Mehlsen, J.[2019]

The Malmö POTS Score (MAPS) effectively quantifies symptom burden in POTS patients, showing a fivefold increase in symptom severity compared to healthy controls, with a total MAPS score of 78 ± 20 for POTS patients versus 14 ± 12 for controls.

MAPS scores correlate significantly with clinical parameters such as heart rate and blood pressure, and a MAPS score of ≥42 can reliably differentiate POTS patients from healthy individuals, indicating its potential as a diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malmö POTS symptom score: Assessing symptom burden in postural orthostatic tachycardia syndrome. Spahic, JM., Hamrefors, V., Johansson, M., et al.[2023]

Cognitive symptoms from Postural Orthostatic Tachycardia Syndrome (POTS) significantly impair daily functioning, affecting both physical and cognitive tasks.

Participants with POTS have developed various strategies to cope with their symptoms, which can inform occupational therapy interventions aimed at enhancing their independence and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognition and Postural Tachycardia Syndrome (POTS): Participant-Identified Challenges and Strategies, and Implications for Intervention. Hollingsworth, C., Boyette, V., Rich, EM., et al.[2022]

In a study of 50 patients with postural tachycardia syndrome (POTS), it was found that they experienced an average heart rate increase of 36 bpm after standing for ten minutes, indicating significant autonomic nervous system involvement.

When using anxiety questionnaires that included autonomic symptoms, POTS patients scored higher for anxiety compared to controls; however, when questionnaires excluded these symptoms, there was no significant difference, suggesting that anxiety in POTS may be related to the physical symptoms rather than a separate anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anxiety in patients with postural tachycardia syndrome (POTS)]. Wagner, C., Isenmann, S., Ringendahl, H., et al.[2015]

In a study of 708 patients with postural orthostatic tachycardia syndrome, various medications were found to effectively manage symptoms, with success rates of 52.2% for light-headedness and 53.4% for pain.

The study highlighted that while insomnia treatment was more effective in females, other symptom therapies showed no gender differences, indicating that medications can be tailored to individual symptoms for better management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilisation of medications to reduce symptoms in children with postural orthostatic tachycardia syndrome. Boris, JR., Bernadzikowski, T.[2019]

In a study of 708 pediatric patients with postural orthostatic tachycardia syndrome, 68.8% showed clinical improvement in fatigue and cognitive dysfunction after medication treatment, indicating that medications can be effective for these symptoms.

The effectiveness of individual medications varied significantly, with methylphenidate showing a 53.1% improvement rate, while atomoxetine had only a 16.5% improvement rate, suggesting that multiple trials of different medications may be necessary to find an effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy for fatigue and cognitive dysfunction in postural orthostatic tachycardia syndrome. Boris, JR., Bernadzikowski, T.[2019]

Postural orthostatic tachycardia syndrome (POTS) is characterized by a significant increase in heart rate when moving to an upright position, often affecting adolescents after periods of inactivity, and can lead to various symptoms like dizziness and fatigue.

Treatment for POTS includes nonpharmacologic strategies such as increased exercise and fluid intake, as well as pharmacologic options like beta-blockers and serotonin reuptake inhibitors, tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome: a clinical review. Johnson, JN., Mack, KJ., Kuntz, NL., et al.[2010]

A 16-year-old boy diagnosed with POTS showed a significant heart rate increase during head-up tilt testing, indicating his condition, which caused symptoms like lightheadedness and weakness without low blood pressure.

Treatment with propranolol effectively relieved his symptoms, and he remained asymptomatic after stopping the medication and making lifestyle changes, suggesting that propranolol is a safe and effective option for managing POTS in this patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of heart rate variability during head-up tilt testing in a patient with idiopathic postural orthostatic tachycardia syndrome (POTS). Sumiyoshi, M., Nakata, Y., Mineda, Y., et al.[2019]

In a study of 121 children and adolescents with postural tachycardia syndrome, the cumulative symptom-free rate improved significantly over time, reaching 85.6% at the 6-year follow-up, indicating that conventional interventions can lead to favorable long-term outcomes.

The duration of symptoms before treatment and the maximum upright heart rate during a standing test were identified as key factors influencing recovery, with longer symptom duration decreasing the likelihood of being symptom-free and higher heart rates improving it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Children and Adolescents With Postural Tachycardia Syndrome After Conventional Treatment. Tao, C., Lu, W., Lin, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11292765/

Long‐Term POTS Outcomes Survey: Diagnosis, Therapy ... The LT‐POTS (Long Term POTS Outcomes Survey) included questions about quality of life, symptoms, therapies, education, employment, and social impact of disease.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40697483/

A Cross-Sectional Survey in Young Women Main Outcome Measures: Gynecologic symptoms and QoL. Results: Regular menstrual cycles were seen in 81/167 participants (49.1%). POTS symptoms ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/postural-orthostatic-tachycardia-syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trials The aims of this study will be to measure changes in postural orthostatic tachycardia syndrome (POTS) symptoms, functional disability and catastrophizing.

4. cambridge.org cambridge.org/core/journals/cardiology-in-the-young/article/pilot-study-using-the-compensatory-reserve-index-to-evaluate-individuals-with-postural-orthostatic-tachycardia-syndrome/89C379045484E854A41915F8DB7EC262

A Pilot Study using the Compensatory Reserve Index to ... Patients with physiologic Postural Orthostatic Tachycardia syndrome had greater declines in Compensatory Reserve Index with orthostatic vitals ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1567708/full

Impact of exercise to treat postural orthostatic tachycardia ... The purpose of this systematic review was to evaluate the impact of exercise on cardiovascular and patient-centered outcomes in patients with POTS.

6. aerjournal.com aerjournal.com/articles/management-postural-tachycardia-syndrome-inappropriate-sinus-tachycardia-and-vasovagal?language_content_entity=en

Management of Postural Tachycardia Syndrome ... There are few data about the long-term outcome. POTS is chronic, without known mortality, and many patients seem to improve over time. POTS ...

7. standinguptopots.org standinguptopots.org/sites/default/files/bok_978-3-030-54165-1.pdf

Postural Tachycardia Syndrome Postural Tachycardia Syndrome is common, distressing, and has symptoms reaching far beyond simple postural tachycardia.