Clinical trial: Ethanol Response in Essential Tremor: Clinical and Neurophysiological Correlates (NCT01200966)

Eligibility criteria:
-  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment