Transcranial Ultrasound Therapy of Essential Tremor (ULTRABRAINTher)
Essential Tremor
About this trial
This is an interventional treatment trial for Essential Tremor
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
Sites / Locations
- Hôpital Pitié Salpétrière
Arms of the Study
Arm 1
Experimental
minimally invasive method for performing thalamotomy
We will study patients with essential tremor with significant disability despite well-conducted drug therapy who have a contraindication to deep brain stimulation or who refuse treatment. In this population, unilateral thalamotomy of Vim by radiosurgery is already considered a valid indication and performed routinely with proven efficacy and morbidity deemed acceptable. It is therefore the population of choice to evaluate for the first time in France the efficacy and safety of a new, minimally invasive method for performing thalamotomy: targeted ultrasound thermal injury at high intensity. This same population will also make it possible to study, for the first time in humans in this indication, the potential of neuromodulation by low frequency low frequency ultrasound beams to improve the guidance before the lesion is achieved.