Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03035513
Other study ID # CHU-0299
Secondary ID 2016-A01149-42
Status Recruiting
Phase N/A
First received January 13, 2017
Last updated January 27, 2017
Start date January 2017
Est. completion date February 2020

Study information

Verified date January 2017
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 0473751195
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date February 2020
Est. primary completion date February 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Continuous spikes and waves during slow sleep (CSWS)


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Some comparisons with electrophysiological and neuropsychological data will be done at day 1