Microstructure Imaging in Stroke Patients

NCT04118790 | Recruiting

• 1 other identifier: TRABIT13
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to establish a methodological framework based on existing advanced neuroimaging technologies as a new clinical neuroimaging tool for assessment of possible affected brain connections in stroke and TIA patients. Thus, providing new insights into microstructural changes that may underline why those patients experience deficits like fatigue.

Conditions

Fatigue; Stroke, Acute; Transient Ischemic Attack

Keywords

Fatigue; minor stroke; TIA; Diffusion; MRI; Quantitative; Sequence; Microstructure; Axon; Myelin; Degeneration

Outcome Measures

Primary Outcomes (1)

• Microstructural changes in the brain network, and its correlate with functional deficits in patients with minor stroke or TIA.

  The study assumes that minor stroke or TIA leads to both axonal Wallerian degeneration and demyelination. These pathological changes in the white matter brain network can be captured with a new microstructural anisotropy MRI measure related to cell density, shapes, and a measure of myelination. Therefore, a new microstructural fractional anisotropy measure is expected to be more sensitive to pathology than traditional estimations using the diffusion tensor models, such as diffusion tensor imaging (DTI). Moreover, the structural MRI measures are expected to correlate with clinical assessment.

  MRI data collected within 3 weeks after the clinical assessment

Study Arms (3)

Minor Stroke patients

* Clinical Assessment * MRI scan session

Other: Clinical Assessment; Procedure: MRI scan

TIA patients

* Clinical Assessment * MRI scan session

Other: Clinical Assessment; Procedure: MRI scan

Healthy Controls

* MRI scan session

Procedure: MRI scan

Interventions

Clinical Assessment OTHER

1. Medical history and details of the vascular incident will be collected from the patient and the medical journal. (Duration: 1hr) 2. Neuropsychological measures collected using test measures and questionaries (duration approx 45-60 min).

Minor Stroke patients; TIA patients

MRI scan PROCEDURE

1\. MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min).

Healthy Controls; Minor Stroke patients; TIA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is in total 90 participants, from which, 3 groups are divided: 30 minor Stroke patients, 30 TIA patients, and 30 healthy controls. * The 2 groups of patients, minor Stroke and TIA, will be recruited from Department of Neurology, Bispebjerg Hospital. * The healthy age- and sex-matched individuals for the control group will be recruited from the general population.

You may qualify if:

• Stroke or TIA (ABCD2\>4 and/or acute Diffusion-Weighted Image (DWI) lesion).
• Modified Rankin Scale \<=2.
• As perceived by the investigator, have the ability to comply with all requirements of the study protocol.
• Have the ability to understand and sign the Informed Consents Form.
• Multidimensional Fatigue Inventory score \>= 12 on general fatigue.

You may not qualify if:

• Pregnancy or lactation; human chorionic gonadotropin (hCG) urine test is offered for women \< 55 years.
• Major medical illness (for instance: anemia, diabetes mellitus, thyroid disorders, cardiovascular disease, electrolyte imbalance, etc.)
• Treated with ritalin or modafinil.
• Known uncontrolled severe malignancy.
• Known drug or alcohol addiction.
• Tiredness due to pharmaceutical side effects, as identified by the Investigator.
• Max body weight of 130 kg.
• Persons who do not wish to be informed about abnormal findings as part of the investigations.
• Pregnancy or lactation; urin hCG test is offered for women \< 55 years.
• Major medical illness (for instance: anemia, diabetes mellitus, thyroid disorders, cardiovascular disease, electrolyte imbalance, etc.)
• Anamnestic infection (cystitis, influenza, pneumonia, etc) the last 3 weeks.
• Known malignancy.
• Known drug or alcohol addiction.
• Tiredness due to pharmaceutical side effects.
• Max body weight of 130 kg.

Sponsors & Collaborators

• Danish Research Centre for Magnetic Resonance: lead
• Bispebjerg Hospital: collaborator

Study Sites (2)

Bispebjerg Hospital

Copenhagen, København NV, 2400, Denmark

RECRUITING

Danish Research Centre for Magnetic Resonance

Copenhagen, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Fatigue; Stroke; Ischemic Attack, Transient

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tim B. Dyrby, Professor

  Danish Research Centre for Magnetic Resonance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria del Carmen Moreno Genis, MSc

CONTACT

38626446; carmenmg@drcmr.dk

Tim Bjørn Dyrby, Professor

CONTACT

38626542; timd@drcmr.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: December 23, 2019
• Primary Completion: September 1, 2023
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)