Clinical trial: Bilateral Treatment of Medication Refractory Essential Tremor (NCT04112381)

Eligibility criteria:
Inclusion Criteria:

          1. Men and women age 22 years or older

          2. Diagnosis of medication-refractory Essential Tremor

          3. Has previously underwent an Exablate index procedure in a clinical trial or in a
             commercial setting at least 9 months prior to enrolling in this trial

          4. Able to communicate sensations during the Exablate thalamotomy procedure

        Exclusion Criteria:

          1. Has experienced any non-transient neurological event or worsening following the
             Exablate index procedure

          2. Presence of unknown or MR unsafe devices anywhere in the body

          3. Non-transient hemiparesis as determined by physical examination

          4. Clinically significant abnormal speech function as determined by a speech pathologist

          5. Pregnant or breastfeeding

          6. Unstable cardiac status

          7. Behavior(s) consistent with ethanol or substance abuse

          8. History of bleeding disorder

          9. Has received anticoagulants within one month of Exablate procedure

         10. Cerebrovascular disease

         11. Intracranial tumor

         12. Active or suspected acute or chronic uncontrolled infection

         13. Has previously had deep brain stimulation or a prior stereotactic ablation of the
             basal ganglia or thalamus

         14. Implanted objects in the skull or the brain

         15. Currently in a clinical trial involving an investigational product or non-approved use
             of a drug or device or in any other type of medical research

         16. Unable to communicate with the investigator and staff
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 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