EpilepsyETAPENCT04379128
Attentional Impairment in People With Epilepsy
An observational study of Epilepsy, run by Central Hospital, Nancy, France.
Trial summary
Epilepsy is one of the most common chronic neurological conditions.It leads to cognitive impairment in 20-50% of patients with a structural form. In comparison with seizures, these cognitive disorders are a major additional factor in occupational, social and family disability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Attentional tasks
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Aug 2025
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: people with epilepsy versus normal control
Who may be able to join
- Patient with epilepsy, according to Fisher et al. (2005).
- Patient with written informed consent
- affiliation to a social security regime is compulsory
- Individuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.
- Patient 18 years of age and older
- Normal controls:
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- Individuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.
- People 18 years of age and older
- People with no neurological and/or psychiatric history
Who cannot join
- for patients: with another progressive neurological condition for all People of full age who are subject to a legal protection measure or who are unable to express their consent People deprived of their liberty by a judicial or administrative decision People who regularly use psychoactive substances (cannabis, alcohol...)
Trial locations and contacts
No sites are listed yet.
About this study
Epilepsy is one of the most common chronic neurological conditions.It leads to cognitive impairment in 20-50% of patients with a structural form.
In comparison with seizures, these cognitive disorders are a major additional factor in occupational, social and family disability. They are particularly frequent (50%) in temporal epilepsies and preferably concern memory and language skills.
Read more
The cognitive consequences of epilepsy are therefore well described in the following areas: episodic memory, language, executive functions.
Concerning attentional abilities, a recent review has highlighted the lack of work in this specific field in order to properly measure the prevalence and nature of attentional disorders in epileptic patients. Indeed, attentional abilities are often mentioned in studies, but attention is a complex domain defined by four modalities: alertness, selective attention, divided attention and sustained attention. No study systematically assesses all of these modalities.
The objective of this study is to evaluate the prevalence and nature of attentional disorders in epileptic patients compared to control subjects.
- Conditions
- Epilepsy
- Being tested
- Attentional tasks
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional tasksOther
a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control
| Study group | Role | What they receive |
|---|---|---|
| patients with epilepsy | Attentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale) Receives: Other: Attentional tasks | |
| Normal controls | Attentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale) Receives: Other: Attentional tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
d2-r
selective attention task
Measured: 10 minutes
Secondary outcomes (3)
sustained attention TAP Subtest
Your task is to press the key as quickly as possible whenever two successive patterns have the same shape
Measured: 15 minutes
alertness attention TAP Subtest
a cross appears on the screen. press the key when the cross appears
Measured: 8 minutes
divided attention TAP Subtest
first task :a cross appears on the screen in which a varying number of crosses appear simultaneously. when four of these crosses form a square, then please press the key as quickly as possible.
second task: in this task you will hear a high and a low tone in sequence. you must decide whether the same tone occurs twice in a row. Please press the key as quickly as possible.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionAug 2025 (estimated)
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 EpilepsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 272 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379128
- Sponsor's protocol ID
- 2019-A02748-49
- Acronym
- ETAPE
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brissart H, Forthoffer N, Maillard L. Attention disorders in adults with epilepsy. Determinants and therapeutic strategies. Rev Neurol (Paris). 2019 Mar;175(3):135-140. doi: 10.1016/j.neurol.2019.01.394. Epub 2019 Feb 28.
PubMed 30826090
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Impairment in People With Epilepsy
- ClinicalTrials.gov ID
- NCT04379128
- Acronym / sponsor ID
- ETAPE / 2019-A02748-49
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 May 2020 (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.
Epilepsy is one of the most common chronic neurological conditions.It leads to cognitive impairment in 20-50% of patients with a structural form.
In comparison with seizures, these cognitive disorders are a major additional factor in occupational, social and family disability. They are particularly frequent (50%) in temporal epilepsies and preferably concern memory and language skills.
The cognitive consequences of epilepsy are therefore well described in the following areas: episodic memory, language, executive functions.
Concerning attentional abilities, a recent review has highlighted the lack of work in this specific field in order to properly measure the prevalence and nature of attentional disorders in epileptic patients. Indeed, attentional abilities are often mentioned in studies, but attention is a complex domain defined by four modalities: alertness, selective attention, divided attention and sustained attention. No study systematically assesses all of these modalities.
The objective of this study is to evaluate the prevalence and nature of attentional disorders in epileptic patients compared to control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with epilepsy | – | Other: Attentional tasksAttentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale) |
| Normal controls | – | Other: Attentional tasksAttentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people with epilepsy versus normal control
Key inclusion criteria (9 listed)
- Patient with epilepsy, according to Fisher et al. (2005).
- Patient with written informed consent
- affiliation to a social security regime is compulsory
- Individuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.
- Patient 18 years of age and older
Key exclusion criteria (1 listed)
- for patients: with another progressive neurological condition for all People of full age who are subject to a legal protection measure or who are unable to express their consent People deprived of their liberty by a judicial or administrative decision People who regularly use psychoactive substances (cannabis, alcohol...)
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 |
|---|---|---|
| Attentional tasksa neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control | Other | Normal controls, patients with epilepsy |
Primary outcome
d2-r
Time frame: 10 minutes
selective attention task
3 secondary outcomes
sustained attention TAP Subtest
Time frame: 15 minutes
alertness attention TAP Subtest
Time frame: 8 minutes
divided attention TAP Subtest
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Results publication: PubMed 30826090Brissart H, Forthoffer N, Maillard L. Attention disorders in adults with epilepsy. Determinants and therapeutic strategies. Rev Neurol (Paris). 2019 Mar;175(3):135-140. doi: 10.1016/j.neurol.2019.01.394. Epub 2019 Feb 28.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Central Hospital, Nancy, 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 1 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 helene BRISSART, Dr (383851689 ext. +33, h.brissart@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
d2-r (time frame: 10 minutes). 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 NCT04379128, 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 7 May 2020.