Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 ā° 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.
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 ā° 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:
Recorded positions:
Examinations 30 minutes after the intervention (study drink):
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Day | Experimental | Participants will receive vodka with rum flavored orange juice with a target blood alcohol of 0.4 ā° 30 minutes after alcohol consumption. The required amount of vodka will be calculated with the Widmark formula. |
|
| Placebo Day | Placebo Comparator | Participants will receive a non-alcoholic rum flavored orange juice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcoholic drink | Dietary Supplement | Participants will receive vodka with rum flavored orange juice with a target blood alcohol of 0.4 ā° 30 minutes after alcohol consumption. The required amount of vodka will be calculated with the Widmark formula. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Petra Schwingenschuh, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8010 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D004421 | Dystonia |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020820 | Dyskinesias |
Not provided
Not provided
| ID | Term |
|---|---|
| D000434 | Alcoholic Beverages |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo drink | Dietary Supplement | Participants will receive a non-alcoholic rum flavored orange juice. |
|
| 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). | 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. | 30 minutes after each study drink. Duration of measurement: 1 minute. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |