Medication Refractory Essential Tremor
Conditions
Interventions
The objective of this prospective, multi-site, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory t
Sponsors
Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women age 20 years or older 2. Subjects who are able and willing to give consent and able to attend all study visits, 3. A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder 4. Have had an inadequate response to one or two oral doses of medication, per local standards. An inadequate medication trial is defined as a therapeutic dose of each medication and poor response to drug, or the development of side effects as the medication dose is titrated. 5. Following the 1-month medication stability period, subject must be on stable medication for tremor a. The 1-Month stability period visit will be 1-month post consent date 6. Subjects on stable antidepressant medications for at least 3 months may be enrolled into this study (i.e., no change in medication drug or dosage for 3 months). 7. Vim nucleus of thalamus can be target by the ExAblate device. The thalamic region must be apparent on MRI such that targeting can be performed by measurement from a line connecting the anterior and posterior commissures of the brain. 8. Able to communicate sensations during the ExAblate TcMRgFUS treatment 9. Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale while stable on medication. 10. May have bilateral appendicular tremor 11. Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities]) 12. Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
Exclusion criteria
Exclusion criteria: 1. Subjects with unstable cardiac status 2. Subjects exhibiting any behaviors consistent with ethanol or substance abuse 3. Severe hypertension 4. Subjects with standard contraindications for MR imaging. 5. Known intolerance or allergies to the MRI contrast agent. 6. Patient with severely impaired renal function or who is on dialysis 7. History of abnormal bleeding or coagulopathy. 8. Receiving anticoagulant or antiplatelet therapy within one week, or drugs 9. Active or suspected acute or chronic uncontrolled infection 10. History of immunocompromise. 11. History of intracranial hemorrhage 12. Cerebrovascular disease 13. Subjects with uncontrolled symptoms and signs of increased intracranial pressure. 14. Individuals who are not able or willing to tolerate the required prolonged stationary supine position. 15. Are participating or have participated in another clinical trial 16. Significant claustrophobia 17. Subjects unable to communicate. 18. Presence of any other neurodegenerative disease such as Parkinson plus syndromes 19. Anyone suspected to have the diagnosis of idiopathic Parkinson's disease. 20. Presence of significant cognitive impairment 21. Subjects with life threatening systemic disease 22. Subjects with a history of seizures 23. Subjects with presence or history of psychosis or active mood disorders will be excluded. 24. Subjects with risk factors for intraoperative or postoperative bleeding. 25. Subjects with brain tumors 26. Pregnancy or lactation. 27. Legal incapacity or limited legal capacity. 28. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia 29. Subjects who have been administered botulinum toxins 30. Subjects who have an Overall Skull Density Ratio of 0.3 or less as calculated from the screening CT. 31. Any illness that in the investigator's opinion preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality life claims : Questionnaire for Essential Tremor ( QUEST ) outcome (upper extremity questions ) at Month 3 change from Baseline 2. Durability ( as measured by QUEST upper arm extremity questions ) of the procedure as reflected by the efficacy data through change from baseline measures througu Month12 follow up 3. Subject daily functionalities : as measured by CRST Part-C ( subscales ) Month 12 as compared to Baseline | — |
Countries
Japan
Contacts
Public ContactEtsuko Shimizu
Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital Clinical Research Center
Outcome results
None listed