NCT02589470

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 3, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2021

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

3.5 years

First QC Date

October 16, 2015

Last Update Submit

October 1, 2018

Conditions

Epilepsy

Keywords

cognitive rehabilitationmemoryepilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

    20 minutes

Secondary Outcomes (5)

  • digit span

    5 minutes

  • Visual memory task

    10 minutes

  • verbal fluencies

    5 minutes

  • Attentional tasks (TEA Battery)

    10 minutes

  • Beck Depression Inventory

    10 minutes

Study Arms (2)

COMETE

EXPERIMENTAL

patients will attend a specific rehabilitation programme of memory

Other: COMETE

CONTROL

NO INTERVENTION

the control group where patients will benefit from a standard treatment

Interventions

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.

COMETE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie, Hôpital Central, CHRU de Nancy

Nancy, Lorraine, 54 035, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21176930BACKGROUND

  • 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.

    PMID: 22853712RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • jean pierre VIGNAL, DR

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

helene brissart, Dr

CONTACT

0033383851689h.brissart@chu-nancy.fr

louis maillard, Pr

CONTACT

0033383852377l.maillard@chu-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 28, 2015

Study Start

March 3, 2016

Primary Completion

September 3, 2019

Study Completion

January 3, 2021

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

FR(1)