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NCT05623644
Multimodal MR Imaging Study on ET and PD Patients Subjected With MRgFUS Thalamotomy
Conditions: Movement Disorders
Sex: All
Enrollment: 200
Sponsor: Chinese PLA General Hospital
Location: China
Summary
The technological advance of magnetic resonance-guided focused ultrasound (MRgFUS) has once again brought lesion therapy back to the clinical frontline for the treatment of movement disorder.
Thus far, the safety of MRgFUS has been widely proven and has just been made available in China in late 2020.
We attempted to analyze the neuroplasticity characteristics and altered neural circuit activity in patients subjected with MRgFUS thalamotomy via Multiple MR Imaging study, and to explore potential biomarkers that could be used to predict the treatment outcome.
Eligibility Criteria
Inclusion Criteria:Any patient who intends to undergo MRgFUS thalamotomy for tremor control will be recruited for additional multimodal MR Imaging scranning;A clear diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;Men and women age 18 years or older;Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;Able to communicate sensations during the ExAblate TcMRgFUS treatment;Having complete medical history and clinical follow up;MR Imaging scanning can be processed.Exclusion Criteria:Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc;Known intolerance or allergies to the MRI contrast agent (e.g.
Gadolinium or Magnevist) including advanced kidney disease;Subjects with unstable cardiac status;Severe hypertension (diastolic BP > 100 on medication);Patient with severely impaired renal function;History of abnormal bleeding and/or coagulopathy;History of immunocompromise including those who are HIV positive;History of intracranial hemorrhage;Cerebrovascular disease (multiple CVA or CVA within 6 months);Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema);Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time);Significant claustrophobia that cannot be managed with mild medication;Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination;Presence of significant cognitive impairment;Subjects with life-threatening systemic disease;Subjects with a history of seizures within the past year;Subjects with presence or history of psychosis.
Source: ClinicalTrials.gov (NCT05623644). StuddyBuddy aggregates publicly available trial information.