Essential TremorNCT06403280
The Effect of Alcohol on Common Tremor Syndromes
A study testing Alcoholic drink in people with Essential Tremor and Dystonia, run by Medical University of Graz at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Tremor, Dystonia, Parkinson Disease
- What is being tested?
- Alcoholic drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of PD, DT, TaD, ET or ETplus based on clinical diagnostic criteria
- tremor in upper extremities
- accompanying person for both study visits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Alcohol on Common Tremor Syndromes - A Prospective Double-blind Randomised Cross-over (Alcohol, Placebo) Study
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?
Read more
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.
Read the 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:
- rest position: arms relaxed and hands hanging freely from the arm rest
- 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
- Being tested
- Alcoholic drink, Placebo drink
- Keywords
- accelerometry, alcohol responsiveness
- Medical subject headings
- Essential Tremor, Dystonia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcoholic drinkDietary 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 drinkDietary supplement
Participants will receive a non-alcoholic rum flavored orange juice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Alcoholic drink |
| Placebo Day | Placebo comparator | Participants will receive a non-alcoholic rum flavored orange juice. Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after each study drink. Duration of measurement: 5 minutes.
Secondary outcomes (3)
Change from baseline in TETRAS-P
Change in The Essential Tremor Rating Scale - Performance Subscale (TETRAS-P) before and after the intervention will be used as clinical parameter of tremor severity in patients with essential tremor, dystonic tremor and tremor associated with dystonia. The TETRAS-P Scale is a 16 item scale with a possible score range between 0 (=no tremor) and 64 points (=worst tremor).
Measured: 30 minutes after each study drink. Duration of measurement: 3 minutes.
Change from baseline in UPDRS III
The change of the motor examination of the Movement Disorder Society-Unified Parkinson´s Disease Rating Scale (part 3) will be used as clinical parameter for tremor and changes in motor examination in patients with Parkinson´s Disease. The UPDRS III is a 32-items scale with a possible score range between 0 (=no motor symptoms) and 128 points (=worst result).
Measured: 30 minutes after each study drink. Duration of measurement: 5 minutes.
Change from baseline in Visual Analogue Scale (VAS)
The change in the Visual Analogue Scale (VAS) is be used to assess the subjective tremor severity. The VAS ranges from 0 to 10, with higher values indicating worse subjective tremor.
Measured: 30 minutes after each study drink. Duration of measurement: 1 minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2024
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Schwingenschuh, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403280
- Sponsor's protocol ID
- EK 35-415 ex 22/23
- Status last verified
- May 2026
- First submitted
- 29 Apr 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alcohol on Common Tremor Syndromes - A Prospective Double-blind Randomised Cross-over (Alcohol, Placebo) Study
- ClinicalTrials.gov ID
- NCT06403280
- Acronym / sponsor ID
- EK 35-415 ex 22/23
- Conditions
- Essential Tremor, Dystonia, Parkinson Disease
- Keywords
- accelerometry, alcohol responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- rest position: arms relaxed and hands hanging freely from the arm rest
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Day | Experimental | Dietary Supplement: Alcoholic drinkParticipants 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 | Placebo comparator | Dietary Supplement: Placebo drinkParticipants will receive a non-alcoholic rum flavored orange juice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of PD, DT, TaD, ET or ETplus based on clinical diagnostic criteria
- tremor in upper extremities
- accompanying person for both study visits
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcoholic drinkParticipants 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 | Interventional Day |
| Placebo drinkParticipants will receive a non-alcoholic rum flavored orange juice. | Dietary supplement | Placebo Day |
Primary outcome
Change from baseline of the Total Tremor Power measured by accelerometry
Time frame: 30 minutes after each study drink. Duration of measurement: 5 minutes.
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.
3 secondary outcomes
Change from baseline in TETRAS-P
Time frame: 30 minutes after each study drink. Duration of measurement: 3 minutes.
Change from baseline in UPDRS III
Time frame: 30 minutes after each study drink. Duration of measurement: 5 minutes.
Change from baseline in Visual Analogue Scale (VAS)
Time frame: 30 minutes after each study drink. Duration of measurement: 1 minute.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Schwingenschuh, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcoholic drink in people with Essential Tremor and Dystonia, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the Total Tremor Power measured by accelerometry (time frame: 30 minutes after each study drink. Duration of measurement: 5 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.