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COMETE Study : COgnitive Rehabilitation of MEmory in Temporal Epilepsy (COMETE)

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ClinicalTrials.gov Identifier: NCT02589470
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
CHU de Reims
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Epilepsy Other: COMETE Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: COMET Study Effectiveness of a Cognitive Remediation Program of Memory in Patients With Temporal Lobe Epilepsy
Actual Study Start Date : March 3, 2016
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : January 3, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COMETE
patients will attend a specific rehabilitation programme of memory
Other: COMETE
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.

No Intervention: CONTROL
the control group where patients will benefit from a standard treatment



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. digit span [ Time Frame: 5 minutes ]
    this is a task of immediate memory : neuropsychologist read digit, and subject must recall them in the same order

  2. Visual memory task [ Time Frame: 10 minutes ]
    this is a task of visual memory : subject must memorize a grid

  3. verbal fluencies [ Time Frame: 5 minutes ]
    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

  4. Attentional tasks (TEA Battery) [ Time Frame: 10 minutes ]
    This is attentional task on computer

  5. Beck Depression Inventory [ Time Frame: 10 minutes ]
    this is an inventory of depression



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589470


Contacts
Contact: helene brissart, Dr 0033383851689 h.brissart@chu-nancy.fr
Contact: louis maillard, Pr 0033383852377 l.maillard@chu-nancy.fr

Locations
France
Service de Neurologie, Hôpital Central, CHRU de Nancy Recruiting
Nancy, Lorraine, France, 54 035
Contact: Helene BRISSART, Dr    +33383851689    h.brissart@chu-nancy.fr   
Contact: Louis MAILLARD, MD PHD    +33383852377    l.maillard@chu-nancy.fr   
Principal Investigator: Jean-Pierre VIGNAL, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
CHU de Reims
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: jean pierre VIGNAL, DR Central Hospital, Nancy, France

Publications of Results:
Other Publications:
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02589470     History of Changes
Other Study ID Numbers: 2015-a00733-46
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

Keywords provided by Central Hospital, Nancy, France:
cognitive rehabilitation
memory
epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases