Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation

NCT ID: NCT05750303

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2023-01-31

Brief Summary

Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation.

Detailed Description

Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. Recovery activity can be reflected both in the clinical assessment of the patient (based on the NIHSS or MRS scale for example) as well as on the biochemical and molecular level. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Furthermore, the collected data will be analyzed in relation to demographics and vascular risk factors. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation. The study group patients will undergo standard post-stroke rehabilitation programme provided by physiotherapist, every day for a period of 3 weeks with weekend gaps.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Subacute ischemic stroke

blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples

No interventions assigned to this group

No ischemic stroke and no other neurological disease control group

blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• subacute ischeamic stroke,
• age over 18,
• informed consent obtained

Exclusion Criteria

• intracerebral haemorrhage,
• chronic or significant acute inflammatory factors,
• neurological illness other than ischeamic stroke,
• severe cardio-vascular disease like myocardial infarction less than 30 days, unstable angina pectoris,
• decompensated metabolic or endocrine diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lodz

UNKNOWN

Sponsor Role: collaborator

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elzbieta Miller, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz

Locations

Medical University of Lodz

Lodz, , Poland

Countries

Poland

Other Identifiers

RNN/105/21/KE

Identifier Type: -

Identifier Source: org_study_id