NCT05580198

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

October 11, 2022

Last Update Submit

October 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-stroke depression

    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

    3 months

Secondary Outcomes (1)

  • Severity of depressive symptoms

    3 months

Study Arms (2)

BRH+

Acute ischemic stroke patients with brainstem raphe hypoechogenicity.

Diagnostic Test: Transcranial sonography.

BRH-

Acute ischemic stroke patients without brainstem raphe hypoechogenicity.

Diagnostic Test: Transcranial sonography.

Interventions

Transcranial sonography examination to determine the brainstem raphe echogenicity.

BRH+BRH-

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who present with an acute ischemic stroke to the emergency department with the onset of symptoms within the past 14 days.

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient transtemporal bone window for transcranial sonography examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josef-Hospital Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Christos Krogias, Prof.

    St. Josef-Hospital Bochum, Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Richter, Dr,

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

January 1, 2021

Primary Completion

November 1, 2022

Study Completion

March 1, 2023

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations