Post Stroke Psychological Distress

Completed

• Conditions: Stroke

• Registration Number: NCT01187342
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

The study design relates to affective symptomatology, particularly poststroke depression and posttraumatic stress symptoms as well as to cognitive decline due to stress-related hypercortisolemia in the early phase after stroke. Extended MRI studies including a functional connectivity (fc-MRI) paradigm have been incorporated to study on subacute midbrain neurodegeneration as a possible morphological correlate of functional and clinical findings.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2023-08
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurence of depression (GDS, SKID)	90 days	Geriatric Depression Scale, Structured Clinical interview for DSM-IV

Secondary Outcome Measures

Name	Time	Method
change in serumcholine	90days	measurement of serumcholine
change in saliva cortisol	90days	measurement of saliva cortisol levels

Trial Locations

Locations (1)

Charité, Campus Benjamin Franklin, Dep. of Neurology; 🇩🇪 Berlin, Germany