Symptomatic Cerebral InfarctionFatigue AVCNCT03288090
Evaluate the Frequency of Fatigue After Cerebral Infarction
An observational study of Symptomatic Cerebral Infarction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Cerebral Infarction
- What is being tested?
- FSS: Fatigue Severity Scale, Neuropsychological evaluation battery and Other functional scores
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2017to 22 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cerebral infarction dating back one week at most
Who may be able to join
- Patients presenting recent symptomatic cerebral infarction (< 1 week) defined according to World Health Organization (WHO) criteria and hospitalised at the Stroke Unit in Dijon University.
- Patients aged 18 years or older.
- Patients who have been informed about the study, or their person of trust for patients unable to express their consent.
Who cannot join
- Patients (or their person of trust) who refuse to participate in the study.
- Subjects in custody.
- Patients presenting prior co-morbidity as a cause of significant fatigue in the opinion of the investigator
- Patients with dementia or aphasia before the stroke
- Patients (or their person of trust) who may be difficult to contact by telephone during the follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue After Stroke
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.
The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.
- Conditions
- Symptomatic Cerebral Infarction
- Being tested
- FSS: Fatigue Severity Scale, Neuropsychological evaluation battery, Other functional scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSS: Fatigue Severity ScaleOther
Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).
Neuropsychological evaluation batteryOther
A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.
Other functional scoresOther
Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale
| Study group | Role | What they receive |
|---|---|---|
| Treated | Not described Receives: Other: FSS: Fatigue Severity Scale; Other: Neuropsychological evaluation battery; Other: Other functional scores | |
| Non-treated | Not described Receives: Other: FSS: Fatigue Severity Scale; Other: Neuropsychological evaluation battery; Other: Other functional scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue evaluated using the Fatigue Severity Scale (FSS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start11 Sep 2017
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288090
- Sponsor's protocol ID
- Béjot 2017
- Acronym
- Fatigue AVC
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Graber M, Garnier L, Duloquin G, Mohr S, Guillemin S, Ramaget O, Piver A, Tainturier C, Bret-Legrand C, Delpont B, Blanc-Labarre C, Gueniat J, Hervieu-Begue M, Osseby GV, Giroud M, Bejot Y. Association Between Fatigue and Cognitive Impairment at 6 Months in Patients With Ischemic Stroke Treated With Acute Revascularization Therapy. Front Neurol. 2019 Aug 28;10:931. doi: 10.3389/fneur.2019.00931. eCollection 2019.
PubMed 31555198
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue After Stroke
- ClinicalTrials.gov ID
- NCT03288090
- Acronym / sponsor ID
- Fatigue AVC / Béjot 2017
- Conditions
- Symptomatic Cerebral Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 19 Sep 2017 (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.
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.
The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | – | Other: FSS: Fatigue Severity Scale, Other: Neuropsychological evaluation battery, Other: Other functional scores |
| Non-treated | – | Other: FSS: Fatigue Severity Scale, Other: Neuropsychological evaluation battery, Other: Other functional scores |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cerebral infarction dating back one week at most
Key inclusion criteria (3 listed)
- Patients presenting recent symptomatic cerebral infarction (< 1 week) defined according to World Health Organization (WHO) criteria and hospitalised at the Stroke Unit in Dijon University.
- Patients aged 18 years or older.
- Patients who have been informed about the study, or their person of trust for patients unable to express their consent.
Key exclusion criteria (5 listed)
- Patients (or their person of trust) who refuse to participate in the study.
- Subjects in custody.
- Patients presenting prior co-morbidity as a cause of significant fatigue in the opinion of the investigator
- Patients with dementia or aphasia before the stroke
- Patients (or their person of trust) who may be difficult to contact by telephone during the follow-up.
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 |
|---|---|---|
| FSS: Fatigue Severity ScaleFatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category). | Other | Non-treated, Treated |
| Neuropsychological evaluation batteryA standardized French neuropsychological battery for the cognitive evaluation of stroke patients. | Other | Non-treated, Treated |
| Other functional scoresRankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale | Other | Non-treated, Treated |
Primary outcome
Fatigue evaluated using the Fatigue Severity Scale (FSS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 31555198Graber M, Garnier L, Duloquin G, Mohr S, Guillemin S, Ramaget O, Piver A, Tainturier C, Bret-Legrand C, Delpont B, Blanc-Labarre C, Gueniat J, Hervieu-Begue M, Osseby GV, Giroud M, Bejot Y. Association Between Fatigue and Cognitive Impairment at 6 Months in Patients With Ischemic Stroke Treated With Acute Revascularization Therapy. Front Neurol. 2019 Aug 28;10:931. doi: 10.3389/fneur.2019.00931. eCollection 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Symptomatic Cerebral Infarction, run by Centre Hospitalier Universitaire Dijon 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue evaluated using the Fatigue Severity Scale (FSS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288090, which also lists 1 linked publication.
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 6 Feb 2026.