MRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value
Movement Disorders
About this trial
This is an interventional treatment trial for Movement Disorders focused on measuring Essential tremor, Parkinson disease, MRgFUS
Eligibility Criteria
Inclusion Criteria: Men and women age 22 years or older; Subjects are able and willing to agree to participate in the study and can accept all research visits; A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder and intolerance to side effects of medication or poor response to medication, severe and disabling tremor; Able to adapt to MRI system; To tolerate operation with or without some form of sedative (e.g., awake sedation); Able to communicate with the doctor during the operation; Able to use the "Stop ultrasonic processing" button; Skull density ratio (SDR) ≥ 0.28. Exclusion Criteria: Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, known intolerance or allergies to the MRI contrast agent (e.g.Gadolinium or Magnevist) including advanced kidney disease, etc; Pregnant woman; Subjects with severely impaired renal function; Subjects with unstable cardiac status or severe hypertension (diastolic BP > 100 on medication); Subjects show behaviors consistent with alcohol or drug abuse; History of abnormal bleeding and/or coagulopathy/ or intracranial hemorrhage; Patients who received anticoagulant therapy or medications known to increase the risk of bleeding within the month prior to receiving focused ultrasound treatment; Cerebrovascular disease (multiple CVA or CVA within 3 months); Subjects with brain tumors. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 2 hrs of total time).
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
MRgFUS treatment