The Effect of Alcohol on Common Tremor Syndromes - A Prospective Double-blind Randomised Cross-over (Alcohol, Placebo) Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this interventional study is to compare the response to alcohol in patients with essential tremor (ET), essential tremor plus (ETplus), dystonic tremor (DT), tremor associated with dystonia (TaD) and tremor in Parkinson´s disease (PD). The main question to be answered is: • Is there a difference in the objective alcohol responsiveness of patients with ET, DT, TaD and PD? Participants will receive either vodka with rum-flavoured orange juice with a target blood alcohol of 0.4 ‰ or a non-alcoholic rum-flavoured orange juice (vice versa on the second study day). Before and 30, 60 an 120 minutes after the study drink the participants will undergo a clinical examination of the tremor and accelerometry will be performed. Researchers will compare alcohol and placebo in a randomized cross over way to see if the effect of alcohol on tremor exceeds the placebo effect.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• diagnosis of PD, DT, TaD, ET or ETplus based on clinical diagnostic criteria

• tremor in upper extremities

• accompanying person for both study visits

Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Contact Information
Primary
Petra Schwingenschuh, MD
petra.schwingenschuh@medunigraz.at
+4331638583379
Backup
Daniela Kern, MD
daniela.eibl@medunigraz.at
+4331638516051
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 45
Treatments
Experimental: Interventional Day
Participants will receive vodka with rum flavored orange juice with a target blood alcohol of 0.4 ‰ 30 minutes after alcohol consumption. The required amount of vodka will be calculated with the Widmark formula.
Placebo_comparator: Placebo Day
Participants will receive a non-alcoholic rum flavored orange juice.
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov