Prognostic Markers of Post-Stroke Depression (PROMoSD)
Study Details
Study Description
Brief Summary
Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Post-stroke depression (PSD) is an important complication after a stroke. Despite significant limitations between studies of PSD risk factors, stroke severity or post-stroke disability, prior depressive episodes, and female sex are arguably the most well-known risk factors for developing PSD, although the predictive value of these factors is limited.
A hypoechogenic brainstem raphe (BR) detected by transcranial sonography (TCS) is associated with depressive symptoms in distinct diseases but is also common with approximately 25% of the non-depressed population in Europe. The primary aim of this study is to investigate the association between BR hypoechogenicity and PSD occurrence in a prospective observational study design.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BRH+ Acute ischemic stroke patients with brainstem raphe hypoechogenicity. |
Diagnostic Test: Transcranial sonography.
Transcranial sonography examination to determine the brainstem raphe echogenicity.
|
| BRH- Acute ischemic stroke patients without brainstem raphe hypoechogenicity. |
Diagnostic Test: Transcranial sonography.
Transcranial sonography examination to determine the brainstem raphe echogenicity.
|
Outcome Measures
Primary Outcome Measures
- Post-stroke depression [3 months]
PSD diagnosis was defined according to the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V criteria) or by any new medication for anti-depressive indication during follow-up
Secondary Outcome Measures
- Severity of depressive symptoms [3 months]
Measured by the Hamilton Depression Rating Scale (HRSD, minimum score: 0, maximum score: 52), with higher scores indicating greater severity of depressive symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Acute ischemic stroke with the onset of symptoms within the past 14 days
-
Diagnosis of AIS is confirmed by brain imaging, either computer tomography or magnetic resonance imaging
Exclusion Criteria:
- Insufficient transtemporal bone window for transcranial sonography examination
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Josef-Hospital Bochum | Bochum | Nordrhein-Westfalen | Germany | 44791 |
Sponsors and Collaborators
- Ruhr University of Bochum
Investigators
- Principal Investigator: Christos Krogias, Prof., St. Josef-Hospital Bochum, Ruhr-University Bochum
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-6862