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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COMETE
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring cognitive rehabilitation, memory, epilepsy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Neurologie, Hôpital Central, CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

COMETE

CONTROL

Arm Description

patients will attend a specific rehabilitation programme of memory

the control group where patients will benefit from a standard treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

digit span
this is a task of immediate memory : neuropsychologist read digit, and subject must recall them in the same order
Visual memory task
this is a task of visual memory : subject must memorize a grid
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
Attentional tasks (TEA Battery)
This is attentional task on computer
Beck Depression Inventory
this is an inventory of depression

Full Information

First Posted
October 16, 2015
Last Updated
October 1, 2018
Sponsor
Central Hospital, Nancy, France
Collaborators
CHU de Reims, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02589470
Brief Title
COMETE Study : COgnitive Rehabilitation of MEmory in Temporal Epilepsy
Acronym
COMETE
Official Title
COMET Study Effectiveness of a Cognitive Remediation Program of Memory in Patients With Temporal Lobe Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2016 (Actual)
Primary Completion Date
September 3, 2019 (Anticipated)
Study Completion Date
January 3, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
CHU de Reims, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
cognitive rehabilitation, memory, epilepsy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COMETE
Arm Type
Experimental
Arm Description
patients will attend a specific rehabilitation programme of memory
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
the control group where patients will benefit from a standard treatment
Intervention Type
Other
Intervention Name(s)
COMETE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Buschke Reminding Test, learning index
Description
this is a task of verbal memory : neuropsychologist read a list of 15 words, and patient must repeat a maximum of them
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
digit span
Description
this is a task of immediate memory : neuropsychologist read digit, and subject must recall them in the same order
Time Frame
5 minutes
Title
Visual memory task
Description
this is a task of visual memory : subject must memorize a grid
Time Frame
10 minutes
Title
verbal fluencies
Description
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
Time Frame
5 minutes
Title
Attentional tasks (TEA Battery)
Description
This is attentional task on computer
Time Frame
10 minutes
Title
Beck Depression Inventory
Description
this is an inventory of depression
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
helene brissart, Dr
Phone
0033383851689
Email
h.brissart@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
louis maillard, Pr
Phone
0033383852377
Email
l.maillard@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean pierre VIGNAL, DR
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie, Hôpital Central, CHRU de Nancy
City
Nancy
State/Province
Lorraine
ZIP/Postal Code
54 035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene BRISSART, Dr
Phone
+33383851689
Email
h.brissart@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Louis MAILLARD, MD PHD
Phone
+33383852377
Email
l.maillard@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Jean-Pierre VIGNAL, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21176930
Citation
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.
Results Reference
background
PubMed Identifier
22853712
Citation
Brissart 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.
Results Reference
result

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COMETE Study : COgnitive Rehabilitation of MEmory in Temporal Epilepsy

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