Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
The Effect of Alcohol on Common Tremor Syndromes
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
The Effect of Alcohol on Common Tremor Syndromes - A Prospective Double-blind Randomised Cross-over Alcohol Placebo Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 04 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
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 04 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 Parkinsons 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 04 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 Parkinsons 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
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 04 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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None