Non-invasive Vagal Neurostimulation in Adolescents with Postural Orthostatic Tachycardia Syndrome

Overview

About this study

The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 total score) in comparison to standard recovery STEPS management.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Ages 12-19 years with Postural Orthostatic Tachycardia as diagnosed from a positive Mayo Clinic Autonomic Reflex Screen.
  • Patient will have a 40 or greater increase in their heart rate during the tilt test without corresponding orthostatic hypotension (a fall in BP of >20 mmHg SBP or 10mm Hg DBP).

Exclusion criteria: 

  • Orthostatic hypotension, pregnancy, prior neck surgery, any metallic implant near the stimulation site,  known cardiac disorder (structural anomaly, prolonged QT interval, arrythmia or history of documented dysrhythmia), or use of feeding tubes.
  • Patients on other autonomic medications other than Metoprolol or Midodrine, inability to independently utilize the GammaCore device, inability to independently complete surveys, or patients receiving hormonal treatments other than OCPs.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/29/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lytitia Shea, M.D.

Closed for enrollment

Contact information:

Brandi Schlichting

(507) 293-9555

Johnson.Brandi1@mayo.edu

More information

Publications

Publications are currently not available