Hypertrophic olivary Degeneration (HOD) Ischemic stroke Hemorrhagic stroke I63 I61 I62 I69
Conditions
Interventions
Group 1: Single-arm study (Patients who meet inclusion criteria will be followed up prospectively for 8 months and present at the Frankfurt Brain Imaging Center (BIC) at 3-4 months and at 7-8 months a
Sponsors
Klinik für Neurologie Universitätsklinikum Frankfurt, Goethe-Universität
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria Intracerebral hemorrhage or cerebral infarction involving the brainstem or the cerebellum Topo-anatomical relation of the stroke lesion to the Guillain Mollaret triangle (a template will be used to define the regions of interest on MRI scans Maximum diameter of the stroke lesion as defined by MRI of 3 cm Maximum time from stroke symptom onset to study inclusion 7 days Signed informed consent form
Exclusion criteria
Exclusion criteria: Exclusion criteria Sopor and coma at planned study inclusion Intensive care treatment at planned study inclusion operative Injury to the Guillain Mollaret triangle during the acute presentation Contraindications to MR imaging (such as pacemakers, ferromagnetic materials in the body, claustrophobia) Age less than 18 at the time of the index event Modified Rankin Scale (mRS) of > 4 points (patient transportation not feasible) Lack of legal competence or ability to consent (e.g. in the case of legal support)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the presence of HOD on follow-up imaging at 7-8 months after the index event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint values are for one the imaging-recorded incidence rate of the HOD at the time point 3-4 months after the index event, analogous to the main target value recorded, as well as identification of lesion localizations at significantly higher risk of HOD occurrence. Other secondary targets include the presence of the clinical syndrome of HOD (rhythmic palatal tremor, Holmes tremor and pendular nystagmus) in 3-4 and in 7-8 months after the index event, respectively. These are clinically recorded by the study team and study centers. In addition, baseline medical data (age, gender), clinical parameters (blood pressure at admission, presence of oral anticoagulation) and clinical outcome parameters (modified Rankin Scale, National Institute of Health Stroke Scale) are correlated with the occurrence of HOD. | — |
Countries
Germany
Contacts
Public ContactMartin Schaller-Paule
Klinik für Neurologie Universitätsklinikum Frankfurt, Goethe-Universität
Outcome results
None listed