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Long-Term Tremor Evaluation In Patients Receiving Incisionless Surgery with FUS

Long-Term Tremor Evaluation In Patients Receiving Incisionless Surgery with FUS - LOTTE in Paris with FUS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016695
Enrollment
200
Registered
2019-02-05
Start date
2019-03-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G25.0 G20.9

Interventions

Group 1: Procedure: 1. Study MRI with DTI, Resting State, Task-based fMRI as well as Clinical Testing and Electro-neurography before clinically indicated MRgFUS therapy 2. Study MRI with DTI, Resting

Sponsors

Universitätsklinik 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
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Observational study without classic endpoint. Aims: 1. Identify optimal thalamic therapy point in the brain for future MRgFUS therapies 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) 3. Generate long-term findings regarding the outcome according to MRgFUS.

Secondary

MeasureTime frame
see above

Countries

Germany

Contacts

Public ContactUllrich Wüllner

Sektion Bewegungsstörungen Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn

ullrich.wuellner@ukbonn.de+49 (0) 228 2871 5712

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026