Clinical trial: Transcranial Ultrasound Therapy of Essential Tremor (NCT04074031)

Eligibility criteria:
Inclusion Criteria:

          -  Men and women, aged 18 to 80

          -  Diagnosis of essential tremor according to the criteria of the Consensus Statement of
             the Movement Disorders Society (MDS)

          -  Patients with significant disability related to their essential Tremor, despite
             well-conducted medical treatment

          -  Stable drug therapy for at least 30 days prior to inclusion

          -  Contraindication or refusal of deep brain stimulation

          -  Patient receiving Social Security or Universal Medical Coverage or any equivalent plan

          -  Person who voluntarily and knowingly agreed to participate in the study (signing of a
             written consent)

        Exclusion criteria :

          -  Other neurological disorder, in particular previous history of multiple stroke or
             cerebral hemorrhage, intracranial aneurysm in the last 6 months

          -  Inability to stop anticoagulant or antiplatelet therapy or any other medication that
             may increase the risk of bleeding during the 2 weeks prior to the procedure

          -  Current state of health causing bleeding and / or abnormal coagulopathy

          -  Unstable cardiac pathology or severe hypertension that cannot be controlled by
             medication (diastolic blood pressure> 100 with drugs).

          -  Previous medical history of brain tumor

          -  Active epilepsy in the year preceding the inclusion

          -  Contraindications to magnetic resonance imaging such as non-compatible implanted metal
             devices (including pacemakers), size limits, etc.

          -  Known hypersensitivity to local anesthetics (Xylocaine 20mg / ml)

          -  Important claustrophobia that cannot be managed with mild medication

          -  Inability to maintain prolonged stationary supine position necessary for treatment
             (3-4 hours)

          -  Woman of childbearing age without means of contraception

          -  Pregnant or lactating woman

          -  Major persons subject to a measure of legal protection (guardianship, curators or
             under the protection of justice)

          -  Subject in exclusion period of another biomedical research or participating in any
             other biomedical stimulation or therapeutic trial

          -  Patients under AME (state medical aid) (except if exemption from affiliation)

          -  Presence of implants in the brain or skull

          -  Patient cannot communicate with the doctor during the treatment procedure

          -  Subjects with behavior compatible with the abuse of ethanol or psychoactive substances

          -  Cerebrovascular disease (multiple stroke or stroke within 6 months)

          -  Patients who have taken CNS (Central Nervous System) medications within the last 6
             months (eg, CNS stimulants, sympathomimetics)

          -  Significant healing in an area on the path of the planned energy path to the treatment
             area

          -  Recourse to neurosurgical treatments for essential tremor (deep brain stimulation or
             gamma knife
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
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