Skip to content

COMETE Study : COgnitive Rehabilitation of MEmory in Temporal Epilepsy

COMET Study Effectiveness of a Cognitive Remediation Program of Memory in Patients With Temporal Lobe Epilepsy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02589470
Acronym
COMETE
Enrollment
120
Registered
2015-10-28
Start date
2016-03-03
Completion date
2021-01-03
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

cognitive rehabilitation, memory, epilepsy

Brief 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. 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.

Interventions

OTHERCOMETE

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.

Sponsors

CHU de Reims
CollaboratorOTHER
University Hospital, Strasbourg, France
CollaboratorOTHER
Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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) * Patient who has given informed consent in writing * Patients with social insurance * Patients with internet connexion for weekly training at home

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Buschke Reminding Test, learning index20 minutesthis is a task of verbal memory : neuropsychologist read a list of 15 words, and patient must repeat a maximum of them

Secondary

MeasureTime frameDescription
digit span5 minutesthis is a task of immediate memory : neuropsychologist read digit, and subject must recall them in the same order
Visual memory task10 minutesthis is a task of visual memory : subject must memorize a grid
verbal fluencies5 minutesThe 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
Attentional tasks (TEA Battery)10 minutesThis is attentional task on computer
Beck Depression Inventory10 minutesthis is an inventory of depression

Countries

France

Contacts

Primary Contacthelene brissart, Dr
h.brissart@chu-nancy.fr0033383851689
Backup Contactlouis maillard, Pr
l.maillard@chu-nancy.fr0033383852377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026