Prognostic Markers of Post-Stroke Depression (PROMoSD)

NCT ID: NCT05580198

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BRH+

Acute ischemic stroke patients with brainstem raphe hypoechogenicity.

Transcranial sonography.

Intervention Type DIAGNOSTIC_TEST

Transcranial sonography examination to determine the brainstem raphe echogenicity.

BRH-

Acute ischemic stroke patients without brainstem raphe hypoechogenicity.

Transcranial sonography.

Intervention Type DIAGNOSTIC_TEST

Transcranial sonography examination to determine the brainstem raphe echogenicity.

Interventions

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Transcranial sonography.

Transcranial sonography examination to determine the brainstem raphe echogenicity.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Christos Krogias

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christos Krogias, Prof.

Role: PRINCIPAL_INVESTIGATOR

St. Josef-Hospital Bochum, Ruhr-University Bochum

Locations

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St. Josef-Hospital Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniel Richter, Dr,

Role: CONTACT

00492345090

Facility Contacts

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Daniel Richter, Dr.

Role: primary

00492345090

References

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Richter D, Ebert A, Mazul-Wach L, Ruland Q, Charles-James J, Gold R, Tsivgoulis G, Juckel G, Krogias C. Prognostic markers of post-stroke depression (PROMoSD): study protocol of a prospective single-center observational study on raphe hypoechogenicity as a predictor of post-stroke depression. Neurol Res Pract. 2022 Dec 9;4(1):59. doi: 10.1186/s42466-022-00225-5.

Reference Type DERIVED
PMID: 36494874 (View on PubMed)

Other Identifiers

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20-6862

Identifier Type: -

Identifier Source: org_study_id

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