Status:
COMPLETED
Ethanol Response in Essential Tremor: Clinical and Neurophysiological Correlates
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Essential Tremor
Eligibility:
All Genders
21+ years
Brief Summary
Background: \- Essential tremor (ET) is a neurological disorder involving uncontrollable shaking, which over time can interfere with mobility and affect routine aspects of daily living. Several medic...
Detailed Description
OBJECTIVE: The objective of this study is to investigate the clinical and electrophysiological correlates of the ethanol response in suppressing the tremor amplitude in patients with essential tremor...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis of essential tremor with bilateral hand tremor as the predominant feature
- Unequivocal spirographic tremor of both hands on screening examination
- Subjects must be willing and safely able to comply with the study protocol and therefore abstain from any medication for the treatment of tremor for a period of at least 5 plasma half-lives of the individual drug prior to study participation. (For Propranolol/Inderal , Gabapentin/Neurontin this will be 1 day; for Primidone/Mysoline : 26 days).
- Subjects must be willing to refrain from alcohol and drinks or food containing caffeine starting 48 hours prior to the study visit(s)
- EXCLUSION CRITERIA:
- Patients with any other significant pathological finding in the neurological examination other than typical symptoms of ET
- Acute or chronic severe medical conditions which would preclude the subject from participating (e.g., severe heart disease NYHA grade 3 or 4, renal failure, hepatic failure, lung disease, uncontrolled hyperthyroidism)
- Subjects with active or past alcohol abuse or dependence
- Elevated liver function parameters (AST, ALT, GGT), higher than the 1.5 fold upper limit of the normal range (as defined by the NIH Clinical Center Laboratory Medicine Department). The limit for AST therefore will be 51 U/l, for ALT 62 U/L, and GGT 128 U/l.
- Female subjects who are pregnant or lactating
- Subjects aged \< 21 years
- Subjects with unable or unwilling to give informed consent
- Subjects unable or unwilling to cooperate with study requirements Use of prescription or OTC medications that interact with ethanol or influence brain excitability (e.g. hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, etc.).
- Known flushing symptoms after alcohol intake or allergy to alcohol.
- ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS ALSO PARTICIPATING IN PHASE 2:
- History of seizure disorder or hearing loss
- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye.
Exclusion
Key Trial Info
Start Date :
August 30 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 4 2017
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01200966
Start Date
August 30 2010
End Date
January 4 2017
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892