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Diffusion Tensor Imaging in Epilepsy With Continuous Spikes and Waves During Sleep (POCS-DTI)

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ClinicalTrials.gov Identifier: NCT03035513
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic encephalopathy. Even if the correlation between the severity of the epilepsy and the cognitive consequences is well established, the mechanisms involved in epileptic cognitive degradation are complex and poorly understood. In CSWS, there are many arguments for the implication of cortical and subcortical cerebral structures. Among them the thalamus seems to play a crucial role. In fact it is strongly implicated in the sleep and this function is determining for learning. Moreover, it is part of the propagation pathway of generalized forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but most of the time conventional MRI is normal. Despite few literature on CSWS, some studies reported abnormal functional connectivity especially in the thalamus.

The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI) and tractography will be useful in CSWS to confirm the implication of a cortico-thalamo-cortical network showing an abnormal structural connectivity. The investigators will try to determinate if a particular thalamic nucleus is concerned and demonstrate a link between the disease severity (duration and cognitive consequences) and the importance of structural abnormalities.

Using resting state functional MRI (fMRI), the investigators will also try to investigate the default mode network. Its implication was also suggested in the literature.


Condition or disease Intervention/treatment
Cryptogenic Epilepsy Other: Continuous spikes and waves during slow sleep (CSWS)

Detailed Description:

Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic encephalopathy. Even if the correlation between the severity of the epilepsy and the cognitive consequences is well established, the mechanisms involved in epileptic cognitive degradation are complex and poorly understood. In CSWS, there are many arguments for the implication of cortical and subcortical cerebral structures. Among them the thalamus seems to play a crucial role. In fact it is strongly implicated in the sleep and this function is determining for learning. Moreover, it is part of the propagation pathway of generalized forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but most of the time conventional MRI is normal. Despite few literature on CSWS, some studies reported abnormal functional connectivity especially in the thalamus.

The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI) and tractography will be useful in CSWS to confirm the implication of a cortico-thalamo-cortical network showing an abnormal structural connectivity. The investigators will try to determinate if a particular thalamic nucleus is concerned and demonstrate a link between the disease severity (duration and cognitive consequences) and the importance of structural abnormalities.

Using resting state functional MRI (fMRI), the investigators will also try to investigate the default mode network. Its implication was also suggested in the literature.


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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Diffusion Tensor Imaging of the Thalamo-cortical Network in Epilepsy With Continuous Spikes and Waves During Sleep
Study Start Date : January 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Group/Cohort Intervention/treatment
CSWS patients
The data of CSWS patients will be statistically compared to healthy volunteers
Other: Continuous spikes and waves during slow sleep (CSWS)
healthy volunteers
The data of CSWS patients will be statistically compared to healthy volunteers
Other: Continuous spikes and waves during slow sleep (CSWS)



Primary Outcome Measures :
  1. Structural connectivity of the thalamo-cortical network [ Time Frame: at day 1 ]

    Structural connectivity of the thalamo-cortical network will be assessed using DTI fractional anisotropy.

    The data of CSWS patients will be statistically compared to healthy volunteers



Secondary Outcome Measures :
  1. Some comparisons with electrophysiological and neuropsychological data will be done [ Time Frame: at day 1 ]


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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients, diagnosis of CSWS according to the current diagnostic criteria (ILAE 2001)
Criteria

Inclusion Criteria:

  • - for the patients, diagnosis of CSWS according to the current diagnostic criteria (ILAE 2001)
  • minimal age of 5 years old
  • written consent to participate in the study from the subjects who could write and/or from the parents or legal representative

Exclusion Criteria:

  • rejection of the patient or its legal representative
  • no respect of inclusion criteria

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): NCT03035513


Contacts
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Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Dominique ROSENBERG University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03035513     History of Changes
Other Study ID Numbers: CHU-0299
2016-A01149-42 ( Other Identifier: 2016-A01149-42 )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

Keywords provided by University Hospital, Clermont-Ferrand:
Continuous spikes
Epilepsy
Nervous system disease
Neuronal plasticity
Diffusion MRI
Functional MRI
waves during slow sleep (CSWS)

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