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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Looming task for Postural Orthostatic Tachycardia Syndrome is an effective treatment?

The available research does not provide specific data on the effectiveness of the Looming task for treating Postural Orthostatic Tachycardia Syndrome. Instead, it discusses various conventional treatments and their outcomes. For example, one study shows that conventional treatments lead to a gradual increase in symptom-free rates over time, reaching 85.6% at the 6-year follow-up. Another study highlights that medications can improve fatigue and cognitive issues in patients, with an overall effectiveness of 68.8%. However, there is no direct comparison or data on the Looming task as a treatment for this condition. ^{1 2 3 4 5}

What safety data exists for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS)?

The safety data for POTS treatments primarily involve non-pharmacologic and pharmacologic approaches. Non-pharmacologic treatments include increasing aerobic exercise, lower-extremity strengthening, increasing fluid/salt intake, psychophysiologic training, and family education. Pharmacologic treatments are case-specific and may include beta-blockers, alpha-adrenergic agents, mineralocorticoids, and serotonin reuptake inhibitors. Minimal data exist on medication outcomes, but some studies have reviewed medication management outcomes in children, assessing the success of therapies based on consistent dosing. Overall, the safety and effectiveness of treatments are evaluated on a case-by-case basis, with interdisciplinary research ongoing to improve management plans. ^{1 6 7 8 9}

Is the treatment for Postural Orthostatic Tachycardia Syndrome (POTS) a promising treatment?

The treatment for POTS is promising because it includes a mix of exercise, diet changes, and sometimes medication, which can help manage symptoms and improve daily life. This approach aims to increase physical activity, improve blood flow, and reduce heart rate spikes, making it easier for people with POTS to handle daily activities. ^{1 2 4 10 11}

Research Team

Gisela Chelimsky, M.D.

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome: a clinical review. [2010]

2. Australia pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome: an underrecognized disorder. [2007]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Children and Adolescents With Postural Tachycardia Syndrome After Conventional Treatment. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cognition and Postural Tachycardia Syndrome (POTS): Participant-Identified Challenges and Strategies, and Implications for Intervention. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Therapy for fatigue and cognitive dysfunction in postural orthostatic tachycardia syndrome. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

[Anxiety in patients with postural tachycardia syndrome (POTS)]. [2015]

7. Japan 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). [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Postural orthostatic tachycardia syndrome]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Utilisation of medications to reduce symptoms in children with postural orthostatic tachycardia syndrome. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome in patients of orthostatic intolerance symptoms: an ambispective study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Malmö POTS symptom score: Assessing symptom burden in postural orthostatic tachycardia syndrome. [2023]