ong-Term Tremor Evaluation In Patients Receiving Incisionless Surgery with FUS
- Conditions
- G25.0G20.9Essential tremor
- Registration Number
- DRKS00016695
- Lead Sponsor
- niversitätsklinik Bonn: NeuroRadiologische Klinik, Radiologische Klinik, Klinik für Neurologie, Neurochirurgische Klinik Hauptverantwortliche der Studie: Prof. Dr. U. Wüllner, Prof. Dr. H. Vatter, Prof. Dr. H. Boecker, Prof. Dr. A. Radbruch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
both sexes, Age 18 and older, patients with a proven movement disorder of the head (tremor, dystonia) or motoric restlessness, who can tolerate the clinically established MRgFUS therapy and are suitable for it
Ability of the patient to give informed consent, MRI capability according to the safety standards defined for the study clinic
Deviation from inclusion criteria, withdrawal of consent, patients who do not meet the criteria for a safe MRI, or who would otherwise be classified as having a high risk according to the general hospital MRI check result, patients included in the screening questionnaire have found MRI or study participation to be a burden.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Observational study without classic endpoint.<br>Aims:<br>1. Identify optimal thalamic therapy point in the brain for future MRgFUS therapies<br>2. to individualize the therapy to the individual patient (optimization of the therapy point, the delivered amount of energy, the point size related to the tremor shape / diagnosis)<br>3. Generate long-term findings regarding the outcome according to MRgFUS.
- Secondary Outcome Measures
Name Time Method see above