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NCT05131334: VNS_CRAV

Auricular Vagal Stimulation in Alcohol Craving

Completed NA Last updated 23 November 2021
What this trial tests

NA trial testing auriStim, for auricular vagal stimulation in Alcohol Withdrawal in 30 participants. Completed in 1 February 2019.

Timeline
1 October 2018
Primary endpoint
31 January 2019
1 February 2019

Quick facts

Lead sponsorMedical University of Vienna
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment30
Start date1 October 2018
Primary completion31 January 2019
Estimated completion1 February 2019
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Vienna

Who can join

Adults 20 to 65, any sex, with Alcohol Withdrawal or Psychophysiologic Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The cause of the vegetative symptoms is a sympathetic driven misbalance of the autonomous nervous system. To restore vegetative balance in alcohol withdrawal syndrome new neuro-modulatory methods, such as percutaneous auricular vagal stimulation (pVNS) could be used. Measuring the pupil size is a suitable method to assess imbalances or dysfunctions of the vegetative regulation in individuals. Objective: The objective of this study is to assess the pupil reaction to the cholinergic antagonist tropicamide in alcohol withdrawal syndrome as a biomarker of the vegetative balance before and after pVNS. Methods: 30 patients aged between 20 and 65 were recruited in this open-label, controlled pilot trial with repeated measure design. pVNS was administered at the left cymba conchae for 72 hours with intermitted stimulation. Pupillometric recording lasted about 60 min and was performed at baseline and following pVNS. The reaction of the pupil to an anticholinergic agent was measured as a receptor-test in terms of a psychophysiological feedback mechanism to pVNS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
    Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124

Verify or expand the search:

Other recruiting trials for Alcohol Withdrawal

Currently open trials in the same condition.

Other Medical University of Vienna trials

Trials by the same sponsor.

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Data sources for this page

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