Fatigability Post StrokeNCT03543280
Evaluation of the Value of Cerebral Perfusion Scintigraphy in the Study of Post-stroke Fatigability
An observational study of Fatigability Post Stroke, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fatigability Post Stroke
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Adult
Study population: Patients with transient ischemic attack, stroke, dissection, TVC
Who may be able to join
- Patients: 18 to 60 years old at the initial diagnosis
- Admission for transient ischemic attack, stroke, dissection, TVC
- RANKIN less than or equal to 2
- Neuropsychological tests at +3 months: MoCA> 26 (to eliminate cognitive deteriorations too important for the good realization of the battery)
- Absence of psychiatric history
- Absence of psychotropic medication
Show all 9Show fewer
- No history of stroke
- No complaint of pre-stroke fatigue
- Having signed the consent form
Who cannot join
- Impossibility of giving the subject or his family enlightened information (subject in emergency situation, difficulties in understanding the subject, etc.)
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Biophysique et de Médecine Nucléaire
Strasbourg, 67098
Izzie Jacques NAMER, 33 3 88 12 75 50, Izzie.Jacques.NAMER@chru-strasbourg.fr
Izzie Jacques NAMER, MD, PhD
About this study
At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Indeed, it has been shown that a good perfusion is linked to a good evolution of the neurological deficit. This test is used routinely to evaluate cerebral perfusion in patients with stroke. This technique was also used to study the mechanisms of post-stroke aphasia and to highlight neuronal disconnections after stroke, a reflection of the functioning of neural networks.
Neuropsychological tests are almost always done at 3 months. Fatigue is studied: PSF scale at 3 months, 6 months and 2 years. Research needs to be continued in this area because the pathophysiology remains unknown and the symptoms are disabling for patients. Using cerebral perfusion imaging would bring elements of understanding of this mechanism and ultimately improve the management of patients.
- Conditions
- Fatigability Post Stroke
- Keywords
- fatigability post stroke, post stroke, high-speed CT, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate fatigue symptoms in stroke patients
Measured: After the period following a stroke: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start23 Feb 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigability Post StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543280
- Sponsor's protocol ID
- 6787
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 1 Jun 2018
- 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 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Value of Cerebral Perfusion Scintigraphy in the Study of Post-stroke Fatigability
- ClinicalTrials.gov ID
- NCT03543280
- Acronym / sponsor ID
- 6787
- Conditions
- Fatigability Post Stroke
- Keywords
- fatigability post stroke, post stroke, high-speed CT, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Jun 2018 (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.
At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Indeed, it has been shown that a good perfusion is linked to a good evolution of the neurological deficit. This test is used routinely to evaluate cerebral perfusion in patients with stroke. This technique was also used to study the mechanisms of post-stroke aphasia and to highlight neuronal disconnections after stroke, a reflection of the functioning of neural networks.
Neuropsychological tests are almost always done at 3 months. Fatigue is studied: PSF scale at 3 months, 6 months and 2 years. Research needs to be continued in this area because the pathophysiology remains unknown and the symptoms are disabling for patients. Using cerebral perfusion imaging would bring elements of understanding of this mechanism and ultimately improve the management of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with transient ischemic attack, stroke, dissection, TVC
Key inclusion criteria (9 listed)
- Patients: 18 to 60 years old at the initial diagnosis
- Admission for transient ischemic attack, stroke, dissection, TVC
- RANKIN less than or equal to 2
- Neuropsychological tests at +3 months: MoCA> 26 (to eliminate cognitive deteriorations too important for the good realization of the battery)
- Absence of psychiatric history
Key exclusion criteria (4 listed)
- Impossibility of giving the subject or his family enlightened information (subject in emergency situation, difficulties in understanding the subject, etc.)
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Refusal of the patient to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate fatigue symptoms in stroke patients
Time frame: After the period following a stroke: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
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Stroke, Ischemic, Cognitive Impairment
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigability Post Stroke, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Izzie Jacques NAMER, MD, PhD (33 3 88 12 75 50, Izzie.Jacques.NAMER@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate fatigue symptoms in stroke patients (time frame: After the period following a stroke: 1 month). 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 1 Jun 2018.