Multicenter prospective analysis of hypertrophic olivary degeneration following infratentorial stroke: Evaluation of disease epidemiology, clinical presentation and MR-imaging aspects

• Conditions: Hypertrophic olivary Degeneration (HOD)Ischemic stroke Hemorrhagic stroke; I63; I61; I62; I69; Cerebral infarction; Intracerebral haemorrhage; Other nontraumatic intracranial haemorrhage; Sequelae of cerebrovascular disease

• Registration Number: DRKS00020549
• Lead Sponsor: Klinik für Neurologie Universitätsklinikum Frankfurt, Goethe-Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-05
• Results First Posted: 2022-08-03
• Study Completion: 2022-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

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
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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the presence of HOD on follow-up imaging at 7-8 months after the index event.

Secondary Outcome Measures

Name	Time	Method
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.