NCT01187342

Brief Summary

Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 31, 2025

Status Verified

August 1, 2023

Enrollment Period

5.3 years

First QC Date

July 1, 2010

Last Update Submit

January 29, 2025

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • occurence of depression (GDS, SKID)

    Geriatric Depression Scale, Structured Clinical interview for DSM-IV

    90 days

Secondary Outcomes (2)

  • change in saliva cortisol

    90days

  • change in serumcholine

    90days

Study Arms (2)

Non-striatal lesion group

acute ischemic Stroke in MCA territory of 10-100 cm³ with sparing of striatocapsular structures

Striatal lesion group

acute ischemic stroke in MCA/AchA territory with involvement of at least 125 mm³ of striatocapsular structures

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with acute ischemic stroke in MCA/AchA territory within 48 hours of onset

You may qualify if:

  • Stroke in MCA/AchA territory of striato-capsular (at least 125mm³) or non-striatal (10-100cm³) involvement
  • MR-imaging can be conducted 24-48 hours of onset
  • preserved communication skills

You may not qualify if:

  • Patients with psychiatric conditions or medication in the last 4 weeks
  • severe medical conditions
  • limited prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, Campus Benjamin Franklin, Dep. of Neurology

Berlin, State of Berlin, 12200, Germany

Location

Related Publications (1)

  • Kufner A, Rios AS, Winter B, Temuulen U, Khalil A, Grittner U, Schoner J, Akdeniz A, Lachmann U, Kronenberg G, Villringer A, Gertz K, Endres M. Neuropsychiatric changes following striatal stroke- results from the observational PostPsyDis study. Neurol Res Pract. 2025 May 12;7(1):32. doi: 10.1186/s42466-025-00390-3.

    PMID: 40350509DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Matthias Endres, MD

    Center for Stroke Research Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD

Study Record Dates

First Submitted

July 1, 2010

First Posted

August 24, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 31, 2025

Record last verified: 2023-08

Locations

DE(1)