FatigueNCT04118790
Microstructure Imaging in Stroke Patients
An observational study of Fatigue and Stroke, Acute, run by Danish Research Centre for Magnetic Resonance at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Stroke, Acute, Transient Ischemic Attack
- What is being tested?
- Clinical Assessment and MRI scan
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- 23 Dec 2019to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Patient Inclusion Criteria:
- 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.
Patient Exclusion Criteria:
- The DRCMR´s general exclusion criteria for MRI research.
- 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.
Healthy Controls Exclusion Criteria:
- The DRCMR´s general exclusion criteria for MRI research.
- 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.
- Persons who do not wish to be informed about abnormal findings as part of the investigations.
Healthy Controls Inclusion Criteria:
- Healthy
- Age- and sex-matched to patient groups.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, København NV, 2400
Hanne Christensen, MD, 38635070, hanne.krarup.christensen@regionh.dk
Hanne Christensen, MD
- Recruiting
Danish Research Centre for Magnetic Resonance
Copenhagen, 2650
Tim B. Dyrby, Professor, 38626542, timd@drcmr.dk
Maria del Carmen Moreno Genis, MSc, 38626446, carmenmg@drcmr.dk
About this study
Official title: New Clinical Magnetic Resonance Technologies for Capturing Brain Microstructure Alterations in Patients With Minor Stroke or Transient Ischemic Attack
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.
Read the detailed description
Background:
Stroke and transient ischemic attack (TIA) patients are often burdened by fatigue and reduced attention span subacutely. The frequency of post-stroke fatigue is estimated to occur in 29-77% of all patients, with the highest burden often reported at 3 months post-stroke. The micro-sized structures that form the brain connection, i.e. White Matter (WM), the low blood flow, and the little collateral blood supply make the WM highly susceptible to ischemic injuries. In the case of stroke or TIA in WM, the surrounding microstructures of the are affected start losing vital nutrients, i.e. oxygen and glucose, which initiate a cascade of cellular dysfunction due to excitotoxicity. As a result, several microstructures deteriorate and degenerate, leading to neuronal damage and reduction of signal conduction. Diagnosis of stroke and TIA relies on clinical findings and imaging, where MRI has become the chosen imaging modality due to the sensitivity to detect brain lesions. However, at the later sub-acute phases of stroke and TIA, the standard clinical MRI sequences lack specificity to map microstructural degeneration/regeneration of the brain connections that project through or nearby the ischemic area. In recent years, new technologies for structural quantitative MRI have emerged that are sensitive to different microstructural features and their anisotropy organization i.e. demyelination and axonal sizes and densities. Using these new MRI methods has the potential to disentangle some of the pathological processes underlying minor stroke phases in a more quantitative way. Previously, a similar MRI study of future directions of clinical MRI technologies was applied to the Multiple Sclerosis disease (MS). The MS disease follows some of the systemic pathological degeneration effects as in minor stroke i.e. axonal degeneration and de-/remyelination. The preliminary results of that study strongly suggest e.g. that the newly introduced MRI modality improves diagnostic value by better correlation with clinical assessment. Furthermore, the combination of MRI modalities provides new insight into pathology only seen in histology.
Objectives:
- To investigate whether new MRI methods can detect the impact of microstructure ischemic changes along brain connections e.g. neuronal degeneration.
- To test the hypothesis that a combination of unique structural MRI measures will synergistically provide patterns of altered brain structure that give rise to excessive fatigue in patients with minor stroke or TIA.
- To evaluate the capability of the new quantitative MRI methods to objectively assess the presence and severity of fatigue by pinpointing the relevant structural brain alterations that contribute to fatigue.
Hypothesis:
The central hypothesis of the study is that a combination of unique MRI measures will synergistically provide a stronger tool to describe the fatigue and cognitive deficits after stroke and TIA in order to predict the functional deficits in minor stroke and TIA. The assumption is that both Wallerian degeneration and demyelination are expected to affect the anisotropy of microstructural measures along the brain network, as they are inferred from diffusion processes on a micrometer length scale.
Methods:
- Participants: 90 participants are expected to be enrolled in this study. The participants are divided by the case-control method to form in total a 3 class group: 30 minor stroke patients, 30 TIA patients, and 30 healthy age- and sex-matched subjects for the control group.
- MRI sequences: Structural MRI (FLAIR, T1-W, T2*, and Magnetization Transfer), Quantitative MRI (Multiparametric mapping), and Diffusion-weighted imaging ( Diffusion Tensor Imaging, Tractography, Neurite Orientation Dispersion and Density Imaging (NODDI) model, and Microscopic Fractional Anisotropy).
- Neuropsychological measures: Fatigue score, estimated by Multidimensional Fatigue Inventory; Depression score, estimated by Major Depression Inventory; Fatigue Scale for Motor and Cognitive Functions; Repeatable Battery for the Assessment of Neuropsychological status; Wechsler Memory Scale-III; Verbal fluency tasks measuring semantic fluency; and Trail making test A and B.
Experimental Design:
- Part 1. Clinical and Cognitive assessment The clinical and cognitive assessments will be carried out at the Department of Neurology at Bispebjerg Hospital. The evaluation of cognitive assessment will be done through a series of tasks and questionnaires, which determine if the patient is eligible for the study.
- Part 2. MRI session The second part will take place within 3 weeks after the clinical assessment of the patients and consist of only 1 scan session. Healthy controls subjects will be included only for this second part with the aim to generate a reference frame of the imaging results on how the normal brain appears. The scan session has a maximum duration of 90 minutes.
Ethical Considerations:
All patients are handled according to best clinical practice and in accordance with Danish and European guidelines. There is no known risk related to MRI in persons with no magnetic metal in the body (e.g. a pacemaker); this is excluded by using a specific questionnaire to screen subjects prior to MRI. The confined space and the noise of the MRI-scanner may cause anxiety in some; therefore, all subjects will be provided with earplugs, and they must not suffer from claustrophobia. The investigators are not responsible for failure to find existing pathology in the MRI scans. However, on occasion the investigator may notice an incidental finding on an MRI scan that seems abnormal, a radiologist will be consulted as to whether the finding merits further investigation, in which case the investigator will contact the participant and/or the primary care physician of the participant to inform the finding. The decision as to whether to proceed with further examination or treatment lies solely with the participant and, if applicable, with the physician of the participant.
Economy:
The project has received funding from the European Union's Horizon 2020 research and innovation program under the Marie Skłodowska-Curie grant agreement No. 765148, European Innovative Training Network (ITN) program entitled TRABIT - "Translational Brain Imaging Training Network".
Importance or relevant to the study:
If the hypotheses of the study are confirmed, MRI-based fatigue imaging will provide an important addition to the clinical assessment based on clinical scores of the subjective perception of fatigue. Such MRI-based methods would pave the way for quantitative measurement of disabling fatigue and thus foster the development and assessment of individualized therapies.
- Conditions
- Fatigue, Stroke, Acute, Transient Ischemic Attack
- Being tested
- Clinical Assessment, MRI scan
- Keywords
- Fatigue, minor stroke, TIA, Diffusion, MRI, Quantitative, Sequence, Microstructure, Axon, Myelin, Degeneration
- Medical subject headings
- Fatigue, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical AssessmentOther
- Medical history and details of the vascular incident will be collected from the patient and the medical journal. (Duration: 1hr)
- Neuropsychological measures collected using test measures and questionaries (duration approx 45-60 min).
MRI scanProcedure or surgery
- MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min).
| Study group | Role | What they receive |
|---|---|---|
| Minor Stroke patients | * Clinical Assessment
* MRI scan session Receives: Other: Clinical Assessment; Procedure: MRI scan | |
| TIA patients | * Clinical Assessment
* MRI scan session Receives: Other: Clinical Assessment; Procedure: MRI scan | |
| Healthy Controls | * MRI scan session Receives: Procedure: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MRI data collected within 3 weeks after the clinical assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start23 Dec 2019
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Research Centre for Magnetic Resonance
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Tim Dyrby, Danish Research Centre for Magnetic Resonance
- Investigators
- Tim B. Dyrby, Professor, Principal investigator, Danish Research Centre for Magnetic Resonance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118790
- Sponsor's protocol ID
- TRABIT13
- Status last verified
- May 2022
- First submitted
- 4 Oct 2019
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Clinical Magnetic Resonance Technologies for Capturing Brain Microstructure Alterations in Patients With Minor Stroke or Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT04118790
- Acronym / sponsor ID
- TRABIT13
- Conditions
- Fatigue, Stroke, Acute, Transient Ischemic Attack
- Keywords
- Fatigue, minor stroke, TIA, Diffusion, MRI, Quantitative, Sequence, Microstructure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Danish Research Centre for Magnetic ResonanceUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Stroke and transient ischemic attack (TIA) patients are often burdened by fatigue and reduced attention span subacutely. The frequency of post-stroke fatigue is estimated to occur in 29-77% of all patients, with the highest burden often reported at 3 months post-stroke. The micro-sized structures that form the brain connection, i.e. White Matter (WM), the low blood flow, and the little collateral blood supply make the WM highly susceptible to ischemic injuries. In the case of stroke or TIA in WM, the surrounding microstructures of the are affected start losing vital nutrients, i.e. oxygen and glucose, which initiate a cascade of cellular dysfunction due to excitotoxicity. As a result, several microstructures deteriorate and degenerate, leading to neuronal damage and reduction of signal conduction. Diagnosis of stroke and TIA relies on clinical findings and imaging, where MRI has become the chosen imaging modality due to the sensitivity to detect brain lesions. However, at the later sub-acute phases of stroke and TIA, the standard clinical MRI sequences lack specificity to map microstructural degeneration/regeneration of the brain connections that project through or nearby the ischemic area. In recent years, new technologies for structural quantitative MRI have emerged that are sensitive to different microstructural features and their anisotropy organization i.e. demyelination and axonal sizes and densities. Using these new MRI methods has the potential to disentangle some of the pathological processes underlying minor stroke phases in a more quantitative way. Previously, a similar MRI study of future directions of clinical MRI technologies was applied to the Multiple Sclerosis disease (MS). The MS disease follows some of the systemic pathological degeneration effects as in minor stroke i.e. axonal degeneration and de-/remyelination. The preliminary results of that study strongly suggest e.g. that the newly introduced MRI modality improves diagnostic value by better correlation with clinical assessment. Furthermore, the combination of MRI modalities provides new insight into pathology only seen in histology.
Objectives:
- To investigate whether new MRI methods can detect the impact of microstructure ischemic changes along brain connections e.g. neuronal degeneration.
- To test the hypothesis that a combination of unique structural MRI measures will synergistically provide patterns of altered brain structure that give rise to excessive fatigue in patients with minor stroke or TIA.
- To evaluate the capability of the new quantitative MRI methods to objectively assess the presence and severity of fatigue by pinpointing the relevant structural brain alterations that contribute to fatigue.
Hypothesis:
The central hypothesis of the study is that a combination of unique MRI measures will synergistically provide a stronger tool to describe the fatigue and cognitive deficits after stroke and TIA in order to predict the functional deficits in minor stroke and TIA. The assumption is that both Wallerian degeneration and demyelination are expected to affect the anisotropy of microstructural measures along the brain network, as they are inferred from diffusion processes on a micrometer length scale.
Methods:
- Participants: 90 participants are expected to be enrolled in this study. The participants are divided by the case-control method to form in total a 3 class group: 30 minor stroke patients, 30 TIA patients, and 30 healthy age- and sex-matched subjects for the control group.
- MRI sequences: Structural MRI (FLAIR, T1-W, T2*, and Magnetization Transfer), Quantitative MRI (Multiparametric mapping), and Diffusion-weighted imaging ( Diffusion Tensor Imaging, Tractography, Neurite Orientation Dispersion and Density Imaging (NODDI) model, and Microscopic Fractional Anisotropy).
- Neuropsychological measures: Fatigue score, estimated by Multidimensional Fatigue Inventory; Depression score, estimated by Major Depression Inventory; Fatigue Scale for Motor and Cognitive Functions; Repeatable Battery for the Assessment of Neuropsychological status; Wechsler Memory Scale-III; Verbal fluency tasks measuring semantic fluency; and Trail making test A and B.
Experimental Design:
- Part 1. Clinical and Cognitive assessment The clinical and cognitive assessments will be carried out at the Department of Neurology at Bispebjerg Hospital. The evaluation of cognitive assessment will be done through a series of tasks and questionnaires, which determine if the patient is eligible for the study.
- Part 2. MRI session The second part will take place within 3 weeks after the clinical assessment of the patients and consist of only 1 scan session. Healthy controls subjects will be included only for this second part with the aim to generate a reference frame of the imaging results on how the normal brain appears. The scan session has a maximum duration of 90 minutes.
Ethical Considerations:
All patients are handled according to best clinical practice and in accordance with Danish and European guidelines. There is no known risk related to MRI in persons with no magnetic metal in the body (e.g. a pacemaker); this is excluded by using a specific questionnaire to screen subjects prior to MRI. The confined space and the noise of the MRI-scanner may cause anxiety in some; therefore, all subjects will be provided with earplugs, and they must not suffer from claustrophobia. The investigators are not responsible for failure to find existing pathology in the MRI scans. However, on occasion the investigator may notice an incidental finding on an MRI scan that seems abnormal, a radiologist will be consulted as to whether the finding merits further investigation, in which case the investigator will contact the participant and/or the primary care physician of the participant to inform the finding. The decision as to whether to proceed with further examination or treatment lies solely with the participant and, if applicable, with the physician of the participant.
Economy:
The project has received funding from the European Union's Horizon 2020 research and innovation program under the Marie Skłodowska-Curie grant agreement No. 765148, European Innovative Training Network (ITN) program entitled TRABIT - "Translational Brain Imaging Training Network".
Importance or relevant to the study:
If the hypotheses of the study are confirmed, MRI-based fatigue imaging will provide an important addition to the clinical assessment based on clinical scores of the subjective perception of fatigue. Such MRI-based methods would pave the way for quantitative measurement of disabling fatigue and thus foster the development and assessment of individualized therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minor Stroke patients | – | Other: Clinical Assessment, Procedure: MRI scan* Clinical Assessment * MRI scan session |
| TIA patients | – | Other: Clinical Assessment, Procedure: MRI scan* Clinical Assessment * MRI scan session |
| Healthy Controls | – | Procedure: MRI scan* MRI scan session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Assessment1. 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). | Other | Minor Stroke patients, TIA patients |
| MRI scan1. MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min). | Procedure or surgery | Healthy Controls, Minor Stroke patients, TIA patients |
Primary outcome
Microstructural changes in the brain network, and its correlate with functional deficits in patients with minor stroke or TIA.
Time frame: MRI data collected within 3 weeks after the clinical assessment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim B. Dyrby, Professor principal investigator
Danish Research Centre for Magnetic Resonance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Stroke, Acute, run by Danish Research Centre for Magnetic Resonance at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria del Carmen Moreno Genis, MSc (38626446, carmenmg@drcmr.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microstructural changes in the brain network, and its correlate with functional deficits in patients with minor stroke or TIA. (time frame: MRI data collected within 3 weeks after the clinical assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.