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Device
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) for Postural Orthostatic Tachycardia Syndrome
N/A
Recruiting
Led By Lytitia Shea, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient's age 12-19 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Study Summary
This trial aims to see if a device called nVNS can help reduce symptoms in teenagers with POTS compared to the usual management.
Who is the study for?
This trial is for adolescents with POTS, a condition causing rapid heartbeat upon standing. Participants should have symptoms of autonomic nervous system disorders and be able to follow the study procedures.Check my eligibility
What is being tested?
The trial tests if nVNS, a non-invasive nerve stimulation therapy, can reduce symptom severity in teens with POTS compared to standard STEPS management protocol which includes lifestyle changes and medications.See study design
What are the potential side effects?
nVNS may cause mild side effects like headache, neck pain or skin irritation at the site of application. The STEPS protocol generally has minimal side effects related to lifestyle adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 19 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in COMPASS-31 scores between individuals in both arms of the study
The change in Child Functional Disability Inventory scores between individuals in both arms of the study
The change in heart rate increase in head up tilt table tests in individuals in both arms of the study
Secondary outcome measures
Does nVNS influence ability to increase exercise duration in adolescent patients with POTS
Does nVNS influence headache frequency in adolescent patients with POTS
Does use of nVNS influence degree of depression in adolescent patients with POTS
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)Experimental Treatment2 Interventions
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
Group II: Standard Postural Orthostatic Tachycardia Syndrome management/ STEPSActive Control1 Intervention
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilize a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,783,412 Total Patients Enrolled
4 Trials studying Postural Orthostatic Tachycardia Syndrome
113 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Lytitia Shea, MDPrincipal InvestigatorMayo Clinic
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