To determine differences in brain activation and networks in alcohol responsive essential tremor versus alcohol resistant essential tremor.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tremor related brain activation will be investigated with EMG and
accelerometry, as a measure for tremor, and fMRI, as a measure for brain
activity.
Secondary outcome
Secondary study parameters apart from EMG-fMRI:
- Resting state fMRI
- Task based fMRI (non-EMG)
- Anatomical MRI
- MoCA scores as covariate
Secondary study parameters related to measures of alcohol responsivity include:
- Bain Findley Spirographs
- Fahn-Tolosa-Marina Essential Tremor Rating Scale, part A, B and C, as a
comprehensive measure of baseline tremor severity
- Visual Analogue Scale, as a patient-based measure of tremor severity
- Blood alcohol level measured with a breath analyser
Background summary
Essential tremor is a common movement disorder and prevalence increases with
age. Treatment response is unpredictable, the strongest known tremor suppressor
is a low-moderate dose of alcohol: 46% of patients show a clear beneficial
response, while the other 54% do not. This difference in alcohol response may
arise from differences in pathophysiology. Currently, it is clear that
essential tremor arises from pathological oscillations in the
cerebello-thalamo-cortical circuit. It is unknown whether the role of the
cerebellum in essential tremor pathophysiology differs between individuals, nor
if these differences predict the response to treatment. We hypothesize that
differences in brain activity underly alcohol-responsive versus
alcohol-resistant essential tremor.
Study objective
To determine differences in brain activation and networks in alcohol responsive
essential tremor versus alcohol resistant essential tremor.
Study design
Cross-sectional study that also includes an intervention. In summary,
alcohol-responsive and alcohol-resistant essential tremor patients as well as
healthy participants will be included in whom we will investigate
tremor-related brain activity in an ON/OFF-alcohol paradigm by means of
functional MRI.
Study burden and risks
The burden on participants will consist of the time spent on this project:
participation will consist of 1 alcohol responsivity test performed at home for
all essential tremor patients, and of 2 visits to the UMCG for fMRI-scans, once
without alcohol intake and once after alcohol intake, for all participants.
Moreover, alcohol intake will result in mild intoxication, which may lead to
slight discomfort or inconvenience as it places constraints on activities such
as participating in traffic or handling machinery. In essential tremor
patients, alcohol intake may lead to a reboud effect with transiently increased
tremor the following morning. There is no direct benefit for individuals to
participate in this study, however, we expect the results will improve our
understanding of essential tremor pathophysiology and this may lead to more
effective treatment for these patients.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of essential tremor
- Age of 18 years or older
Exclusion criteria
- Pregnancy
- History of (previous) alcohol misuse
- Medication incompatible with alcohol intake
- No alcohol consumption in the previous year
- MR contra-indications. Presence of MR-incompatible metals for instance after
surgical procedures may be verified with a single X-ray if clinical
documentation is insufficient.
For participants with essential tremor:
- (Very) mild tremor
For healthy participants:
- A first degree relative with essential tremor.
- Cognitive impairments defined as MoCA <26
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83904.042.23 |