Cryptogenic EpilepsyPOCS-DTINCT03035513
Diffusion Tensor Imaging in Epilepsy With Continuous Spikes and Waves During Sleep
An observational study of Cryptogenic Epilepsy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryptogenic Epilepsy
- What is being tested?
- Continuous spikes and waves during slow sleep (CSWS)
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients, diagnosis of CSWS according to the current diagnostic criteria (ILAE 2001)
Who may be able to join
- - 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
Who cannot join
- rejection of the patient or its legal representative
- no respect of inclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
About this study
Official title: Diffusion Tensor Imaging of the Thalamo-cortical Network in Epilepsy With Continuous Spikes and Waves During Sleep
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.
Read the 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.
- Conditions
- Cryptogenic Epilepsy
- Being tested
- Continuous spikes and waves during slow sleep (CSWS)
- Keywords
- Continuous spikes, Epilepsy, Nervous system disease, Neuronal plasticity, Diffusion MRI, Functional MRI, waves during slow sleep (CSWS)
- Medical subject headings
- Epilepsy, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous spikes and waves during slow sleep (CSWS)Other
| Study group | Role | What they receive |
|---|---|---|
| CSWS patients | The data of CSWS patients will be statistically compared to healthy volunteers Receives: Other: Continuous spikes and waves during slow sleep (CSWS) | |
| healthy volunteers | The data of CSWS patients will be statistically compared to healthy volunteers Receives: Other: Continuous spikes and waves during slow sleep (CSWS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (1)
Some comparisons with electrophysiological and neuropsychological data will be done
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique ROSENBERG, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035513
- Sponsor's protocol ID
- CHU-0299
- Other IDs
- 2016-A01149-42
- Acronym
- POCS-DTI
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging of the Thalamo-cortical Network in Epilepsy With Continuous Spikes and Waves During Sleep
- ClinicalTrials.gov ID
- NCT03035513
- Acronym / sponsor ID
- POCS-DTI / CHU-0299
- Conditions
- Cryptogenic Epilepsy
- Keywords
- Continuous spikes, Epilepsy, Nervous system disease, Neuronal plasticity, Diffusion MRI, Functional MRI, waves during slow sleep (CSWS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSWS patients | – | Other: Continuous spikes and waves during slow sleep (CSWS)The data of CSWS patients will be statistically compared to healthy volunteers |
| healthy volunteers | – | Other: Continuous spikes and waves during slow sleep (CSWS)The data of CSWS patients will be statistically compared to healthy volunteers |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients, diagnosis of CSWS according to the current diagnostic criteria (ILAE 2001)
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (2 listed)
- rejection of the patient or its legal representative
- no respect of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous spikes and waves during slow sleep (CSWS) | Other | CSWS patients, healthy volunteers |
Primary outcome
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
1 secondary outcome
Some comparisons with electrophysiological and neuropsychological data will be done
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique ROSENBERG principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Epilepsy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural connectivity of the thalamo-cortical network (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.