Clinical trial: Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor (NCT02827955)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with essential tremor defined criteria Consensus statement of the movement
             Disorder Society on Classical Essential Tremor (1998), with trembling of the upper
             limbs causing functional impairment justifying surgical therapy.

          -  Man or woman aged 20 to 85 years.

          -  Patient having an absolute contraindication against or on Deep Brain Stimulation (DBS)
             of the VIM.

          -  Patient who received a first effective unilateral thalamotomy on tremor with a
             satisfactory clinical outcome (no cognitive impairment, lack of postural disorder
             Musculoskeletal severe lack of dysarthria). The first effective thalamotomy will be
             characterized by an improved score of tremor ≥ 45% and improved functional gene ≥ 50%.

          -  Patient who received a first unilateral thalamotomy with satisfactory radiological
             evolution. Unsatisfactory radiological evolution will be characterized by a contrast
             uptake> 350 mm3 one year with edema on T2 and Flair sequences extended beyond the
             internal capsule.

          -  Patient requiring contralateral treatment because of the severity of the tremor and
             functional impairment.

          -  Patient affiliated to a social protection scheme.

          -  Patient who understood and signed the informed consent form (signature of a third
             person possible when the patient is unable to read and / or write but in a state to
             give consent).

        Exclusion Criteria:

          -  Patient with against-indication for performing a brain MRI (pacemaker, intracranial
             metallic objects etc.)

          -  Patient with an against-indication to radiosurgical treatment (prior treatment with
             cerebral radiotherapy)

          -  Pregnant or lactating women

          -  Women of childbearing potential unless

               1. surgical sterilization

               2. use of effective contraception (intrauterine device or method more hormonal
                  barrier method), and requiring to present a test pregnancy by assaying the
                  negative serum with chorionic gonadotrope hormon (CGH) when selecting and accept
                  to remain under the current form of contraception for the duration of the study
                  (in women past menopause should be amenorrheic for at least 12 months to be
                  considered as no longer able to bear a child).

          -  simultaneous participation in another clinical trial or exclusion period of a previous
             clinical trial.

          -  vulnerable persons: minors, protected adults (guardianship) and Major unable to
             consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 85 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