Diffusion Tensor Imaging in Epilepsy With Continuous Spikes and Waves During Sleep

NCT03035513 | Unknown

• 2 other identifiers: CHU-02992016-A01149-42
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryptogenic Epilepsy

Keywords

Continuous spikes; Epilepsy; Nervous system disease; Neuronal plasticity; Diffusion MRI; Functional MRI; waves during slow sleep (CSWS)

Outcome Measures

Primary Outcomes (1)

• Structural connectivity of the thalamo-cortical network

  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

  at day 1

Secondary Outcomes (1)

• Some comparisons with electrophysiological and neuropsychological data will be done

  at day 1

Study Arms (2)

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)

Interventions

Continuous spikes and waves during slow sleep (CSWS) OTHER

CSWS patients; healthy volunteers

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients, diagnosis of CSWS according to the current diagnostic criteria (ILAE 2001)

You may qualify if:

• \- 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

You may not qualify if:

• rejection of the patient or its legal representative

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Epilepsy; Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases

Study Officials

• Dominique ROSENBERG

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 30, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

FR (1)