EpilepsyCOMETENCT02589470
COMETE Study : COgnitive Rehabilitation of MEmory in Temporal Epilepsy
A study testing COMETE in people with Epilepsy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Studies on the cognitive function have highlighted promising results concerning attention. In contrast, in the field of memory, the single cohort study that has been carried out, has not been randomised, with non comparable groups, the significant outcomes are therefore to be balanced. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- COMETE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2016to 3 Jan 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with structural temporal lobe epilepsy, according to Fischer et al (2005) criteria.
- Patients aged 18-70
- Patients with epilepsy for more than 2 year
- Patients with mild to severe memory impairment (minimum score : -1,6σ / average at Buschke Reminding Test, learning index
- Patients with equal or higher Intellectual Quotient than 70 (WAIS-IV)
- stabilized anti epileptic treatment (same treatment for the last 6 months)
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- Patient who has given informed consent in writing
- Patients with social insurance
- Patients with internet connexion for weekly training at home
Who cannot join
- other progressive associated neurological (history of stroke for example) or psychiatric disease
- temporal lobe surgery within following 12 months
- presence of a progressive brain lesion
- legally protected adults or adults incapable of giving informed consent
- persons who are deprived of their liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Neurologie, Hôpital Central, CHRU de Nancy
Nancy, Lorraine, 54 035
Helene BRISSART, Dr, +33383851689, h.brissart@chu-nancy.fr
Louis MAILLARD, MD PHD, +33383852377, l.maillard@chu-nancy.fr
About this study
Official title: COMET Study Effectiveness of a Cognitive Remediation Program of Memory in Patients With Temporal Lobe Epilepsy
Studies on the cognitive function have highlighted promising results concerning attention. In contrast, in the field of memory, the single cohort study that has been carried out, has not been randomised, with non comparable groups, the significant outcomes are therefore to be balanced.
In this study, patients with focal and structural temporal lobe epilepsy will be randomised in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme of memory and the control group where patients will benefit from a standard treatment.
Read the detailed description
Epilepsy is a chronic neurological disease among the most frequent ones. It causes cognitive disorders in 20 to 50 percent of patients with structural epilepsy, that is to say in connexion with an identified or presumed cerebral lesion. Compared to seizures, these cognitive disorders are a major additional factor of professional, social or family disability. They are particularly prevalent (50%) in temporal lobe epilepsy and preferentially affect language memory and abilities. These disorders are well described, they are multifactorial but no (drug and/or non drug) therapy has been validated yet.
Recently, techniques of cognitive rehabilitation have shown benefits in some neurological diseases, like multiple sclerosis.
Concerning adulthood epilepsy, the few cognitive rehabilitation studies that have been conducted present huge methodological gaps limiting the scope of theirs results.
Studies on the cognitive function have highlighted promising results concerning attention. In contrast, in the field of memory, the single cohort study that has been carried out, has not been randomised, with non comparable groups, the significant outcomes are therefore to be balanced.
Thus, in this study, patients with focal and structural temporal lobe epilepsy will be randomised in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme of memory and the control group where patients will benefit from a standard treatment.
Work's hypothesis would be that patients undergoing the rehabilitation programme would present improved learning abilities (with impact on their memory performances) compared to patients with standard treatment.
This hypothesis is based on underlying theories of cognitive rehabilitation. This method predicts that by reinforcing some cognitive abilities that transfer to others, the improved learning abilities will also result in improved abilities in immediate memory, work memory, but will have no effect on verbal inhibition abilities, which will constitute a specific marker/indicator ? for the intervention. Moreover, patient care may have an impact on their quality of life and mood which are predictive factors for a good social and professional integration: that's why these indexes/criteria have to be measured.
- Conditions
- Epilepsy
- Being tested
- COMETE
- Keywords
- cognitive rehabilitation, memory, epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMETEOther
Patients of COMETE group will attend 12 individual sessions of cognitive rehabilitation, which are not systematic in usual treatment, and will receive memory exercises via internet to continue cognitive exercizes at home.
| Study group | Role | What they receive |
|---|---|---|
| COMETE | Experimental | patients will attend a specific rehabilitation programme of memory Receives: Other: COMETE |
| CONTROL | No intervention | the control group where patients will benefit from a standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buschke Reminding Test, learning index
this is a task of verbal memory : neuropsychologist read a list of 15 words, and patient must repeat a maximum of them
Measured: 20 minutes
Secondary outcomes (5)
digit span
this is a task of immediate memory : neuropsychologist read digit, and subject must recall them in the same order
Measured: 5 minutes
Visual memory task
this is a task of visual memory : subject must memorize a grid
Measured: 10 minutes
verbal fluencies
The performance measure is the total number of words that patient give in two minutes. there is two conditions : phonological condition : patient must recall words that start with the letter P; semantic condition : patient must recall words from animal category
Measured: 5 minutes
Attentional tasks (TEA Battery)
This is attentional task on computer
Measured: 10 minutes
Beck Depression Inventory
this is an inventory of depression
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start3 Mar 2016
- Primary completion3 Sep 2019 (estimated)
- Study completion3 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Reims, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- jean pierre VIGNAL, DR, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589470
- Sponsor's protocol ID
- 2015-a00733-46
- Acronym
- COMETE
- Status last verified
- Sep 2018
- First submitted
- 16 Oct 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brissart H, Daniel F, Morele E, Leroy M, Debouverie M, Defer GL. [Cognitive rehabilitation in multiple sclerosis: a review of the literature]. Rev Neurol (Paris). 2011 Apr;167(4):280-90. doi: 10.1016/j.neurol.2010.07.039. Epub 2010 Dec 21. French.
PubMed 21176930Brissart H, Leroy M, Morele E, Baumann C, Spitz E, Debouverie M. Cognitive rehabilitation in multiple sclerosis. Neurocase. 2013;19(6):553-65. doi: 10.1080/13554794.2012.701644. Epub 2012 Aug 1.
PubMed 22853712
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMET Study Effectiveness of a Cognitive Remediation Program of Memory in Patients With Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT02589470
- Acronym / sponsor ID
- COMETE / 2015-a00733-46
- Conditions
- Epilepsy
- Keywords
- cognitive rehabilitation, memory, epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- CHU de Reims, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 3 Sep 2019 (estimated)
- Study completion
- 3 Jan 2021 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- 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.
Studies on the cognitive function have highlighted promising results concerning attention. In contrast, in the field of memory, the single cohort study that has been carried out, has not been randomised, with non comparable groups, the significant outcomes are therefore to be balanced.
In this study, patients with focal and structural temporal lobe epilepsy will be randomised in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme of memory and the control group where patients will benefit from a standard treatment.
Detailed description
Epilepsy is a chronic neurological disease among the most frequent ones. It causes cognitive disorders in 20 to 50 percent of patients with structural epilepsy, that is to say in connexion with an identified or presumed cerebral lesion. Compared to seizures, these cognitive disorders are a major additional factor of professional, social or family disability. They are particularly prevalent (50%) in temporal lobe epilepsy and preferentially affect language memory and abilities. These disorders are well described, they are multifactorial but no (drug and/or non drug) therapy has been validated yet.
Recently, techniques of cognitive rehabilitation have shown benefits in some neurological diseases, like multiple sclerosis.
Concerning adulthood epilepsy, the few cognitive rehabilitation studies that have been conducted present huge methodological gaps limiting the scope of theirs results.
Studies on the cognitive function have highlighted promising results concerning attention. In contrast, in the field of memory, the single cohort study that has been carried out, has not been randomised, with non comparable groups, the significant outcomes are therefore to be balanced.
Thus, in this study, patients with focal and structural temporal lobe epilepsy will be randomised in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme of memory and the control group where patients will benefit from a standard treatment.
Work's hypothesis would be that patients undergoing the rehabilitation programme would present improved learning abilities (with impact on their memory performances) compared to patients with standard treatment.
This hypothesis is based on underlying theories of cognitive rehabilitation. This method predicts that by reinforcing some cognitive abilities that transfer to others, the improved learning abilities will also result in improved abilities in immediate memory, work memory, but will have no effect on verbal inhibition abilities, which will constitute a specific marker/indicator ? for the intervention. Moreover, patient care may have an impact on their quality of life and mood which are predictive factors for a good social and professional integration: that's why these indexes/criteria have to be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMETE | Experimental | Other: COMETEpatients will attend a specific rehabilitation programme of memory |
| CONTROL | No intervention | –the control group where patients will benefit from a standard treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults with structural temporal lobe epilepsy, according to Fischer et al (2005) criteria.
- Patients aged 18-70
- Patients with epilepsy for more than 2 year
- Patients with mild to severe memory impairment (minimum score : -1,6σ / average at Buschke Reminding Test, learning index
- Patients with equal or higher Intellectual Quotient than 70 (WAIS-IV)
Key exclusion criteria (5 listed)
- other progressive associated neurological (history of stroke for example) or psychiatric disease
- temporal lobe surgery within following 12 months
- presence of a progressive brain lesion
- legally protected adults or adults incapable of giving informed consent
- persons who are deprived of their liberty by judicial or administrative decision
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 |
|---|---|---|
| COMETEPatients of COMETE group will attend 12 individual sessions of cognitive rehabilitation, which are not systematic in usual treatment, and will receive memory exercises via internet to continue cognitive exercizes at home. | Other | COMETE |
Primary outcome
Buschke Reminding Test, learning index
Time frame: 20 minutes
this is a task of verbal memory : neuropsychologist read a list of 15 words, and patient must repeat a maximum of them
5 secondary outcomes
digit span
Time frame: 5 minutes
Visual memory task
Time frame: 10 minutes
verbal fluencies
Time frame: 5 minutes
Attentional tasks (TEA Battery)
Time frame: 10 minutes
Beck Depression Inventory
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Background: PubMed 21176930Brissart H, Daniel F, Morele E, Leroy M, Debouverie M, Defer GL. [Cognitive rehabilitation in multiple sclerosis: a review of the literature]. Rev Neurol (Paris). 2011 Apr;167(4):280-90. doi: 10.1016/j.neurol.2010.07.039. Epub 2010 Dec 21. French.
- Results publication: PubMed 22853712Brissart H, Leroy M, Morele E, Baumann C, Spitz E, Debouverie M. Cognitive rehabilitation in multiple sclerosis. Neurocase. 2013;19(6):553-65. doi: 10.1080/13554794.2012.701644. Epub 2012 Aug 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.
jean pierre VIGNAL, DR principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMETE in people with Epilepsy, run by Central Hospital, Nancy, 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 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: status not confirmed, as of the sponsor's last update on 2 Oct 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 helene brissart, Dr (0033383851689, h.brissart@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buschke Reminding Test, learning index (time frame: 20 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 NCT02589470, which also lists 2 linked publications.
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 2 Oct 2018.