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Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Postural Orthostatic Tachycardia Syndrome (POTS)

NCT04632134 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-06-30

No results posted yet for this study

Summary

Postural Orthostatic Tachycardia Syndrome (POTS) is characterized by symptoms of chronic orthostatic intolerance such as fatigue, lightheadedness, dizziness, palpitations and by pronounced tachycardia upon standing.

The aims of the present research study are to test whether a daily transcutaneous vagal nerve stimulation (tVNS) performed for 14 consecutive days may improve heart rate response and reduce disabling symptoms while standing.

Conditions

  • Orthostatic Intolerance
  • Postural Tachycardia Syndrome
  • Syncope, Postural
  • Physical Disability
  • Autonomic Dysfunction

Interventions

DEVICE

Transcutaneous vagal nerve stimulation (tVNS)

Transcutaneous vagal nerve stimulation (tVNS) will be performed using a noninvasive battery powered Transcutaneous Electrical Nerve Stimulation device (Nemos ©; Cerbomed, Germany). Electrical stimulation will be delivered by external electrodes through the skin surface at the conca of right external ear. Electrical current will be applied continuously with a pulse width of 200 μs and pulse frequency of 25 Hz. Stimulation amplitude will be adjusted between 0.1-6 mA, to a maximal amplitude level without causing patient discomfort.

OTHER

Placebo

tVNS electrodes will be positioned in the right ear of the POTS patients without delivering stimulus (Sham)

DEVICE

Home daily transcutaneous vagal nerve stimulation

The home stimulation will consist of 4 hours of stimulation by the tVNS device organized as a 4 sessions of 1 hour. The home stimulation will last for 14 consecutive days.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Raffaello Furlan, Prof · Humanitas Research Hospital; Humanitas University

  • Franca Barbic, MD · Humanitas Research Hospital; Humanitas University

  • Dana Shiffer, MD · Humanitas Research Hospital IRCCS, Rozzano-Milan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-10
Primary Completion
2022-06-30
Completion
2022-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632134 on ClinicalTrials.gov