Clinical trial: Transcranial Stimulation for Essential Tremor (NCT03025529)

Eligibility criteria:
Inclusion Criteria for ET subjects:

          1. Outpatients with essential tremor as diagnosed and confirmed by movement disorder
             specialist

          2. Women of child-bearing potential must provide a negative pregnancy test at entry into
             the study

          3. Stable doses of all medications for at least 14 days prior to study entry and for the
             duration of the study,

          4. At least a 1cm amplitude tremor as judged by the screener using a ruler

        Inclusion Criteria for Healthy Volunteers:

          1. Healthy subjects without tremor and without significant neurologic disease suggestive
             of cerebellar ataxia or other neurodegenerative diseases

          2. Ages 18-80

        Exclusion Criteria:

          1. Any unstable illness or concomitant medical condition that, in the investigator's
             opinion, precludes participation in this study, including disorders that may affect
             gait or balance (i.e., stroke, arthritis, etc).

          2. Pregnancy or lactation.

          3. Concurrent participation in another clinical study.

          4. Dementia or other psychiatric illness that prevents the patient from giving informed
             consent (Montreal Cognitive Assessment Score score less than or equal to 21).

          5. Legal incapacity or limited legal capacity.

          6. Tremor derived from any cause other than essential tremor (Parkinson's disease,
             drug-induced, anxiety-induced) in the clinical assessment at screening

          7. Currently taking lithium or amiodarone or any other drug judged to be contributing to
             tremor as judged by the investigator (may be a cause of tremor)

          8. No medication is an absolute exclusion from TMS. Medications will be reviewed by the
             responsible MD and a decision about inclusion will be made based on the following:

               -  The patient's past medical history, drug dose, history of recent medication
                  changes or duration of treatment, and combination with other Central Nervous
                  System active drugs.

               -  The published TMS guidelines review of medications to be considered with TMS

          9. History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or
             family history of treatment resistant epilepsy with the exception of a single seizure
             of benign etiology (e.g. febrile seizures) in the judgement of the investigator

         10. TMS and MRI-Specific exclusion criteria including:

               -  Known metal in the head (such as a surgical aneurysm clip) or a history of prior
                  neurosurgical procedures.

               -  Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic
                  means, such as cochlear implants, pacemakers, medication pumps, vagal
                  stimulators, deep brain stimulators, neurostimulators, biostimulators, or
                  ventriculo-peritoneal shunts.

               -  Subjects who have or might have bullet fragments or other shrapnel (veterans or
                  workers exposed to metal in their work environment).

               -  Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic
                  eyeliner)

               -  Subjects expressing significant claustrophobia.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years

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