The Effect of Alcohol on Common Tremor Syndromes

NCT06403280 | Recruiting

• 1 other identifier: EK 35-415 ex 22/23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor; Dystonia; Parkinson Disease

Keywords

accelerometry; alcohol responsiveness

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the Total Tremor Power measured by accelerometry

  The the total tremor power (TP) of the spectra between 1 and 30 Hz for each axis will be used. The square root of the sum of the squares of the TP of each accelerometer axis will be calculated. This will be the Change of the Total Tremor Power and will serve as a surrogate for tremor amplitude.

  30 minutes after each study drink. Duration of measurement: 5 minutes.

Secondary Outcomes (3)

• Change from baseline in TETRAS-P

  30 minutes after each study drink. Duration of measurement: 3 minutes.

• Change from baseline in UPDRS III

  30 minutes after each study drink. Duration of measurement: 5 minutes.

• Change from baseline in Visual Analogue Scale (VAS)

  30 minutes after each study drink. Duration of measurement: 1 minute.

Study Arms (2)

Interventional Day

EXPERIMENTAL

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.

Dietary Supplement: Alcoholic drink

Placebo Day

PLACEBO COMPARATOR

Participants will receive a non-alcoholic rum flavored orange juice.

Dietary Supplement: Placebo drink

Interventions

Alcoholic drink DIETARY_SUPPLEMENT

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.

Interventional Day

Placebo drink DIETARY_SUPPLEMENT

Participants will receive a non-alcoholic rum flavored orange juice.

Placebo Day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of PD, DT, TaD, ET or ETplus based on clinical diagnostic criteria
• tremor in upper extremities
• accompanying person for both study visits

You may not qualify if:

• persons that are not willing to abstain from driving at both study days
• patients with diseases prohibiting alcohol ingestion
• patients with a history of alcohol abuse
• pregnancy

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Essential Tremor; Dystonia; Parkinson Disease

Interventions

Alcoholic Beverages

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Petra Schwingenschuh, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Schwingenschuh, MD

CONTACT

+4331638583379; petra.schwingenschuh@medunigraz.at

Daniela Kern, MD

CONTACT

+4331638516051; daniela.eibl@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 7, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)