Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Postural Orthostatic Tachycardia Syndrome (POTS)
VAG-POTS
1 other identifier
interventional
23
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedStudy Start
First participant enrolled
November 10, 2019
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJune 30, 2022
June 1, 2021
2.6 years
September 4, 2019
June 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Autonomic symptoms
Autonomic symptoms will be assessed by the Composite Autonomic Symptom Scale (COMPASS 31) questionnaire. This is based on 31 items and a score ranging from 0 to100, 0 being the absence of symptom and 100 the greatest symptom intensity. The COMPASS 31 will be used to quantify the following autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary and pupillomotor dysfunction symptoms.
Change from baseline Autonomic symptoms at 14 days
Secondary Outcomes (3)
Change in Heart rate
Change from baseline cardiovascular autonomic profile at 14 days
Change in blood pressure
Change from baseline cardiovascular autonomic profile at 14 days
Change in respiration rate
Change from baseline cardiovascular autonomic profile at 14 days
Study Arms (1)
Transcutaneous vagal nerve stimulation (tVNS)
EXPERIMENTALAfter positioning the tVNS electrodes in the right ear but without delivering tVNS (Sham tVNS), above mentioned signals will be recorded for 10 minutes while supine, for 15 minutes during 75° head-up tilt. The same protocol will be performed during active tVNS. The tVNS will be performed while 15 minutes in supine position and during 75°head-up Tilt. Thereafter, every patient will be provided with a Nemos© device and electrodes for home daily stimulation. Daily stimulation will consist of 4 hours of stimulation organized as 4 sessions each lasting 1 hour, to be applied at the patient's convenience.
Interventions
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.
tVNS electrodes will be positioned in the right ear of the POTS patients without delivering stimulus (Sham)
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Postural Orthostatic Tachycardia Syndrome
- Older than 18 years
You may not qualify if:
- Dysautonomias other than POTS
- Neurodegenerative diseases
- History/family history of seizures
- Atrial fibrillation and other relevant cardiac rhythm disturbances
- Chronic inflammatory diseases
- Chronic use on anti-inflammatory drugs
- Diabetes
- Other neurological or psychiatric diseases
- Pacemakers or other electronic implants inserted into the body
- Coronary disorders
- Elevated intracranial blood pressure
- Assumption of drugs facilitating seizures
- Assumption ofpsychiatric drugs
- Alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanitas Research Hospital
Rozzano, 20089Raffaello, Italy
Related Publications (9)
Raj SR. Postural tachycardia syndrome (POTS). Circulation. 2013 Jun 11;127(23):2336-42. doi: 10.1161/CIRCULATIONAHA.112.144501. No abstract available.
PMID: 23753844BACKGROUNDRobertson D. The epidemic of orthostatic tachycardia and orthostatic intolerance. Am J Med Sci. 1999 Feb;317(2):75-7. doi: 10.1097/00000441-199902000-00001. No abstract available.
PMID: 10037110BACKGROUNDFurlan R, Jacob G, Snell M, Robertson D, Porta A, Harris P, Mosqueda-Garcia R. Chronic orthostatic intolerance: a disorder with discordant cardiac and vascular sympathetic control. Circulation. 1998 Nov 17;98(20):2154-9. doi: 10.1161/01.cir.98.20.2154.
PMID: 9815870BACKGROUNDClancy JA, Mary DA, Witte KK, Greenwood JP, Deuchars SA, Deuchars J. Non-invasive vagus nerve stimulation in healthy humans reduces sympathetic nerve activity. Brain Stimul. 2014 Nov-Dec;7(6):871-7. doi: 10.1016/j.brs.2014.07.031. Epub 2014 Jul 16.
PMID: 25164906BACKGROUNDNapadow V, Edwards RR, Cahalan CM, Mensing G, Greenbaum S, Valovska A, Li A, Kim J, Maeda Y, Park K, Wasan AD. Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med. 2012 Jun;13(6):777-89. doi: 10.1111/j.1526-4637.2012.01385.x. Epub 2012 May 8.
PMID: 22568773BACKGROUNDFu Q, Vangundy TB, Galbreath MM, Shibata S, Jain M, Hastings JL, Bhella PS, Levine BD. Cardiac origins of the postural orthostatic tachycardia syndrome. J Am Coll Cardiol. 2010 Jun 22;55(25):2858-68. doi: 10.1016/j.jacc.2010.02.043.
PMID: 20579544BACKGROUNDMurray AR, Atkinson L, Mahadi MK, Deuchars SA, Deuchars J. The strange case of the ear and the heart: The auricular vagus nerve and its influence on cardiac control. Auton Neurosci. 2016 Aug;199:48-53. doi: 10.1016/j.autneu.2016.06.004. Epub 2016 Jun 28.
PMID: 27388046BACKGROUNDFurlan R, Porta A, Costa F, Tank J, Baker L, Schiavi R, Robertson D, Malliani A, Mosqueda-Garcia R. Oscillatory patterns in sympathetic neural discharge and cardiovascular variables during orthostatic stimulus. Circulation. 2000 Feb 29;101(8):886-92. doi: 10.1161/01.cir.101.8.886.
PMID: 10694528BACKGROUNDLow PA. Composite autonomic scoring scale for laboratory quantification of generalized autonomic failure. Mayo Clin Proc. 1993 Aug;68(8):748-52. doi: 10.1016/s0025-6196(12)60631-4.
PMID: 8392653BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raffaello Furlan, Prof
Humanitas Research Hospital; Humanitas University
- STUDY CHAIR
Franca Barbic, MD
Humanitas Research Hospital; Humanitas University
- PRINCIPAL INVESTIGATOR
Dana Shiffer, MD
Humanitas Research Hospital IRCCS, Rozzano-Milan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2019
First Posted
November 17, 2020
Study Start
November 10, 2019
Primary Completion
June 30, 2022
Study Completion
December 30, 2022
Last Updated
June 30, 2022
Record last verified: 2021-06