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Cognitive Impact of Benzodiazepin Withdrawn After Curative Epilepsy Surgery in Children With Focal Epilepsy (COGNIBENZO)

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ClinicalTrials.gov Identifier: NCT03803046
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Epilepsy is a frequent group of diseases, affecting 1% of the general population with a higher incidence in children. Anti-epileptic drugs are used as part of the drug treatment. Even if children with epilepsy have its own characteristics, as in adults, the choice of an anti-epileptic treatment is also based on the benefit-risk balance. The purpose of the treatment should not only be the seizure control. The occurence of side effects is a major factor to be taken into account. In the special populatIon of children with resistant epilepsy (20 to 30% of epilepsy), the treatment goal is not any more to be seizure free but to achieve the lowest possible frequency of seizures with the lowest level of side effects.

When assessing the benefit-risk balance of antiepileptic treatment, it is important to keep in mind that the child is a developing human being whose main activity is learning. Special attention should be paid to minimize treatments with excessive cognitive consequences. Be particularly wary of combination therapies (combinations of several antiepileptic treatments). Indeed, it is well established that they are more harmful than monotherapy. It is also important to avoid the use of drugs with too strong a cognitive effect. Some molecules such as phenobarbital or topiramate have been the subject of a few studies that have established their deleterious effect on the cognitive level. Among antiepileptics, benzodiazepines are sometimes used as disease-modifying therapy. In France, clobazam is the clonazepam have a Marketing Authorization for children.

However, there is no study to determine whether these molecules have cognitive consequences. In order to have more data to better establish the risk-benefit balance of benzodiazepines in the treatment of children with epilepsy, the investigators wish to conduct work to evaluate the cognitive consequences of benzodiazepines in children treated for epilepsy.


Condition or disease
Cognitive Impact of Antiepileptic Drugs

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Impact of Benzodiazepin Withdrawn After Curative Epilepsy Surgery in Children With Focal Epilepsy
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : November 2022





Primary Outcome Measures :
  1. Change in Working memory (Digits Backward - Digit Span assessment) from Visit 2 to visit 3 (aka before and after benzodiazepine discontinuation) in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit (visit 2, before benzodiazepine tapering) and a second at 3-month visit after benzodiazepine discontinuation (visit 3) ]
    For this test (Digit Span assessment), the examiner tells the child a series of increasingly long numbers and asks the child to repeat this series of numbers from the last to the first. This is a standardized (age-specific) test with a score from 1 to 19 with an average score of 10. This test is used to evaluate the working memory.


Secondary Outcome Measures :
  1. Change in short-term memory (Digits Forward - Digit Span assessment) from before to after benzodiazepine discontinuation in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit and a second at 3-month visit after benzodiazepine discontinuation ]
    The examiner tells the child a series of increasingly long numbers that he must repeat immediately after the examiner in the same order as the one presented (2 numbers, then 3 numbers,...). This is a standardized (age-specific) test with a score from 1 to 19 with an average score of 10. This test is used to evaluate short-term memory

  2. Change in spacial working memory (forward Corsi Block) from before to after benzodiazepine discontinuation in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit and a second at 3-month visit after benzodiazepine discontinuation ]
    The examiner presents a board to the child on which are glued small identical cubes. The examiner will touch 2 cubes successively with the index finger and asks the child to touch the same cubes in the same order as him, then 3 cubes, then 4 cubes,... This is a standardized test (on age). This test is used to evaluate visuo-spacial short-term memory

  3. Change in spacial working memory (backward Corsi Block) from before to after benzodiazepine discontinuation in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit and a second at 3-month visit after benzodiazepine discontinuation ]
    The examiner presents a board to the child on which are glued small identical cubes. The examiner will touch with the index finger successively 2 cubes (then 3 cubes,...) and asks the child to touch the cubes starting with the last one until the 1st. This is an age-standardized test. This test is used to evaluate the spacial working memory

  4. Change in attention (TEA-Ch ("Test of Everyday Attention for Children")) from before to after benzodiazepine discontinuation in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit and a second at 3-month visit after benzodiazepine discontinuation ]
    This standardized test is used to evaluate the different components of attention. This is a test commonly used to study attention functions from 1h30 to 2h. TEA-Ch makes it possible to establish a diagnosis of attention deficit but above all to define more precisely the deficient modality: sustained attention, focused attention and attentional control. Different tests are proposed (search in the sky, gunfire, do two things at a time, listen to two things at a time...). There are two forms A and B that test the effect of an intervention to modify attention (to avoid the retest effect). This is a standardized test (on age).

  5. Change in visual attention and visual rapidity from before to after benzodiazepine discontinuation in post surgical seizure free children benzodiazepine discontinuation in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit and a second at 3-month visit after benzodiazepine discontinuation ]
    This is a 1-minute timed target barrage test (rabbits and cats for the youngest and female and male faces for the oldest). It is a A Developmental Neuropsychological Assessment(NEPSY) subtest. It is a question of discriminating against one of the two entities. The number of targets analyzed by the patient allows us to score the level of attention. This is a standardized test (on age).

  6. Change in executive function attention and rapidity (Purdue Pegboard test) from before to after benzodiazepine discontinuation in post surgical seizure free children [ Time Frame: Two assessments will be conducted: One in post-operative seizure-free patient at 3-month postoperative visit and a second at 3-month visit after benzodiazepine discontinuation ]
    This is a timed test where the child must place rods in holes for 1 minute: first with the dominant hand, then the non-dominant hand and then in a two-handed situation. This is a standardized test (on age).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be included among children being followed for drug-resistant epilepsy in pre-surgical assessment by the coordinator team or one of the partners.
Criteria

Inclusion Criteria:

  • Inclusion criteria :
  • Children aged 6 years to 14 years and 10 months
  • Epilepsy patients with drug-resistant focal epilepsy with programmed curative surgical management
  • Subject with IQ greater than 70 (Evaluation of IQ in pre-surgical evaluation)
  • Antiepileptic drug regimen comprising a benzodiazepine daily
  • Subject beneficiary of French national social security scheme
  • Parental (and the child if he or she is of age to do so) have signed the study consent

Exclusion Criteria:

  • Patient unable to perform cognitive tests or unwilling to do them
  • Planned change in drug regimen before the post-surgical period
  • Denied to participate in the research

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): NCT03803046


Contacts
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Contact: Adina ILEA, Dr 06.45.37.03.54 ext 033 adina.ilea@aphp.fr
Contact: Stéphane AUVIN, MD,PHD 01.40.03.36.37 ext 033 stephane.auvin@aphp.fr

Locations
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France
CHU Robert-Debré
Paris, Ile De France, France, 75019
Contact: Yannick VACHER    01.44.84.17.30    yannick.vacher@aphp.fr   
Contact: Sarra POCHON    01 42 16 75 74    sarra.pochon@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Adina ILEA, Dr Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03803046    
Other Study ID Numbers: P160945J
2017-003685-27 ( EudraCT Number )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Benzodiazepin
Children
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases