The Effect of Alcohol on Common Tremor Syndromes

NCT ID: NCT06403280

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-02-28

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.

Detailed Description

The researchers will include 45 patients (9 each) with essential tremor (ET), essential tremor plus (ETplus), dystonic tremor (DT), tremor associated with dystonia (DaT) or tremor in Parkinson´s disease (PD) from the Movement Disorders Outpatients Clinic of the Medical University of Graz.

Participants will be asked to stop any tremor influencing medication and alcohol intake 24 hours before testing. 4 hours before testing the participants should not eat or drink anything. The participants will be asked to bring an accompanying person and are not allowed to drive at the day of the study visit.

Each participant will be examined at two different days (intervention and placebo day) with at least one day in between. During the study participation the tremor influencing medication should not be changed. The study design is a randomized cross sectional design where each participant receives either alcohol or placebo and vice versa on the second study day. The participants will be asked to finish the study drink within 15 minutes.

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 day:

Participants will receive non-alcoholic rum flavored orange juice.

Baseline examinations:

• Questionnaire (only on the first study visit): demographics, disease duration, onset of disease, alcohol drinking habits and noticed effects of alcohol on tremor
• Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
• The Essential Tremor Ranking Scale (TETRAS)
• The Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
• Placement of an indwelling venous cannula in a cubital fossa vein (for repeated blood alcohol measurements)
• Accelerometry: The participants will sit in a chair with a triaxial accelerometer transducer attached to the dorsal surface of the middle phalanx of the index finger. Each position will be recorded 30 seconds.

Recorded positions:

1. rest position: arms relaxed and hands hanging freely from the arm rest

2. posture position: arms / wrists outstretched at shoulder level

Examinations 30 minutes after the intervention (study drink):

• TETRAS Performance Subscale
• MDS-UPDRS motor examination (part III)
• BFM scale
• Accelerometry
• Evaluation of possible side effects

Conditions

Essential Tremor; Dystonia; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Alcoholic drink

Intervention Type: 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.

Placebo Day

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

Group Type: PLACEBO_COMPARATOR

Placebo drink

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Alcoholic drink

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo drink

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra Schwingenschuh, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Petra Schwingenschuh, MD

Role: CONTACT

petra.schwingenschuh@medunigraz.at

+4331638583379

Daniela Kern, MD

Role: CONTACT

daniela.eibl@medunigraz.at

+4331638516051

Facility Contacts

Daniela Kern, MD

Role: primary

daniela.eibl@medunigraz.at

+4331638516051

Petra Schwingenschuh, MD

Role: backup

petra.schwingenschuh@medunigraz.at

+4331638583379

Other Identifiers

EK 35-415 ex 22/23

Identifier Type: -

Identifier Source: org_study_id