NCT05131334

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

October 15, 2021

Last Update Submit

November 10, 2021

Conditions

Alcohol WithdrawalPsychophysiologic Reaction

Keywords

alcohol withdrawalvagal stimulationpupillometry

Outcome Measures

Primary Outcomes (1)

  • mean pupillary diameter

    change of the mean pupillary diameter in millimeter (mm), provoked by the parasympatholytic agent tropicamide (1 drop of 0.01% tropicamide solution administered into the left eye)

    3 days

Secondary Outcomes (6)

  • resting pupillary diameter (millimeter)

    3 days

  • latency (milliseconds)

    3 days

  • amplitude of constriction (millimeter)

    3 days

  • constrictive ratio (percent)

    3 days

  • duration of constriction (milliseconds)

    3 days

  • +1 more secondary outcomes

Study Arms (1)

intervention group

OTHER

The pilot study applied an open-label, unblinded, repeated measures design with three time points of pupillometry measurements at two testing days. Patient serving as their own controls

Device: auriStim, for auricular vagal stimulation

Interventions

auriStim, for auricular vagal stimulationDEVICE

For auricular vagal stimulation we used auriStim (AU0115, Multisana GmbH, Vienna, Austria). Using a green light-emitting diode (LEDs) flashlight, blood vessels in the cymba conchae of the left ear side were detected. Minimal invasive needles (penetrating 1-2mm) were placed close to the vessel-bifurcation to provide efficient stimulation of the auricular branch of the vagus nerve. The built-in microchip controls monophasic volt pulses of 1 ms, with alternating polarity, a frequency of 1 Hz and an amplitude of 4V. Stimulation lasted for 72h in total with alternating on/off periods of three hours. Thereafter, the device was removed, and patients continued their therapy consisting of anti-withdrawal medication.

intervention group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of alcohol dependence according to ICD-10 and DSM-V
  • aged between 20 and 65
  • Ability to perform oral and written informed consent to the study protocol

You may not qualify if:

  • age under 20 or over 65 years
  • taking medication affecting the pupillary measurements (opioids, acetylcholinesterase inhibitors, sympathomimetics)
  • positive pregnancy test
  • diagnosed anxiety disorders
  • multiple substance abuse disorder
  • ocular disease
  • delirious patients
  • biochemical implants
  • hemophilia
  • psoriasis vulgaris

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Vienna, 1090, Austria

Location

Study Officials

  • Henriette Walter, Prof.

    Department of Psychiatry and Psychotherapy, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2021

First Posted

November 23, 2021

Study Start

October 1, 2018

Primary Completion

January 31, 2019

Study Completion

February 1, 2019

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)