Multimodal MR Imaging Study on ET and PD Patients Subjected With MRgFUS Thalamotomy (NCT05623644) | Clinical Trial Compass
UnknownNot Applicable
Multimodal MR Imaging Study on ET and PD Patients Subjected With MRgFUS Thalamotomy
China200 participantsStarted 2022-09-30
Plain-language 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.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
What they're measuring
1
Tremor measurement in ET/PD patients subject with MRgFUS thalamotomy
Timeframe: 5 years
2
Adverse reactions in ET/PD patients subject with MRgFUS thalamotomy
Timeframe: 5 years
3
Imaging features in ET/PD patients subject with MRgFUS thalamotomy
Timeframe: 5 years
4
Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients