Status:
UNKNOWN
Transcranial Ultrasound Therapy of Essential Tremor
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Essential Tremor
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Context. Essential tremor (ET) is a common disease, disabling in severe forms and resistant to drug treatment. In patients with severe ET, invasive neurosurgical technique such as deep brain stimulati...
Detailed Description
Context: Essential tremor (ET) is the most common movement disorder, with a prevalence of 1-4% of the general population. ET is characterized by a rapid (6 and 12 Hz) attitude tremor with rhythmic os...
Eligibility Criteria
Inclusion
- 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 essential tremor drug therapy for at least 30 days prior to inclusion
- Contraindication or refusal or preference 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 :
- 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).
- 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. including presence of implants in the brain or skull)
- 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)
- Patient cannot communicate with the doctor during the treatment procedure
- Subjects with behavior compatible with the abuse of ethanol or psychoactive substances
- Progressive neurological pathology other than TE, stroke or cerebral hemorrhage \< 6 months, multiple stroke ATCD, brain tumor or intracranial aneurysm
- Patients who have taken in the last 6 months drugs lowering the epileptogenic threshold significantly (CNS stimulants, sympathomimetics, neuroleptics, imipraminic antidepressants, amantadine, fampridine, fluoroquinolones, mefloquine)
- 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
Exclusion
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04074031
Start Date
January 7 2020
End Date
October 4 2024
Last Update
January 25 2024
Active Locations (1)
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1
Hôpital Pitié Salpétrière
Paris, France, 75013