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Completed

NCT Number: NCT05750303

Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Lodz

Lodz, 93-113, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation

    Time frame: baseline and 3 weeks later

    IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 level in plasma - unit measure: ng/mL.

  2. changes from baseline IGF-1 expression in whole blood sample at 3 week of rehabilitation

    Time frame: baseline and 3 weeks later

    IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 mRNA gene expression is presented as -ΔCt

  3. changes from baseline in VEGF level in plasma at 3 week of rehabilitation

    Time frame: baseline and 3 weeks later

    VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF level in plasma - unit measure: pg/mL.

  4. changes from baseline in VEGF expression in whole blood sample at 3 week of rehabilitation

    Time frame: baseline and 3 weeks later

    VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF mRNA gene expression is presented as -ΔCt

  5. changes from baseline in MMP-9 level in plasma at 3 week of rehabilitation

    Time frame: baseline and 3 weeks later

    MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 level in plasma - unit of measure: pg/mL.

  6. changes from baseline in MMP-9 expression in whole blood sample at 3 week of rehabilitation

    Time frame: baseline and 3 weeks later

    MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 mRNA gene expression is presented as -ΔCt

  7. changes form baseline in Mini Mental State Examination (MMSE) scale at 3-week rehabilitation

    Time frame: baseline and 3 weeks later

    Mini Mental State Examination is effective, screening tool for cognitive impairment, the maximum score for the MMSE is 30, a cut-off score of 23/24 (or below) indicates dementia, a score of 25 or higher is classed as normal

  8. changes form baseline in The Geriatric Depression Scale (GDS) at 3-week rehabilitation

    Time frame: baseline and 3 weeks later

    The Geriatric Depression Scale is self-reported validated measure of depression in older adults, consists of 15 questions, users respond in a "Yes/No" format, scores 0-4 are considered normal, more than 5 indicate depression: 5-8 mild, 9-11 moderate and 12-15 severe depressive symptoms

  9. changes form baseline in Barthel index scale at 3-week rehabilitation

    Time frame: baseline and 3 weeks later

    Barthel index is a scale used to measure performance in activities of daily living, the 10 items including the Barthel Index pay attention to self-care and mobility. Total possible scores range from 0 - 20, with lower scores indicating increased disability, a score of 17 represents normal ability.

  10. changes form baseline in National Institutes of Health Stroke Scale (NIHSS) scale at 3-week rehabilitation

    Time frame: baseline and 3 weeks later

    National Institutes of Health Stroke Scale is a tool used to objectively quantify the impairment caused by stroke,total score ranging from 0 to 42 and the higher the score, the more severe the stroke

  11. changes form baseline in Modified Rankin Scale (MRS) at 3-week rehabilitation

    Time frame: baseline and 3 weeks later

    Modified Rankin Scale measures degree of disability after stroke, ranges from grade 0 indicating a lack of symptoms to grade 6 indicating dead

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Collaborators

  • University of Lodz

Registry information

Official study title

Circulating Serum VEGF, IGF-1 and MMP-9 and Expression of Their Genes as Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation - Prospective Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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