Epilepsy, Temporal LobeCON-INSULANCT04871555
Structural Cartography of the Insula in Temporal Epilepsy Patients
An observational study of Epilepsy, Temporal Lobe and MRI Scans, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Temporal Lobe, MRI Scans
- What is being tested?
- MRI
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 31 Dec 2022
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: temporal epilepsy patients and healthy subjects healthy subjects will be selected in the healthy cohort of Nguyen G-Dang (Ghaziri et al., 2017)
Who may be able to join
- epileptic patients: temporal epilepsy or temporal plus epilepsy (temporomesial epilepsy, basal temporal epilepsy, mesio lateral or lateral epilepsy, temporo insular epilepsy, operculo insular epilepsy)
- patients who underwent video EEG monitoring with recorded seizures (at least one)
- patients who underwent a brain MRI with DTI sequence before epilepsy surgery
- patients who did not refuse the use of their clinical and MRI data for this study
Who cannot join
- patients younger than 15 years old
- patients with previous brain surgery (before MRI)
- uncompleted MRI sequences (DTI, T1 anatomical)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.
Read the detailed description
The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.
- Conditions
- Epilepsy, Temporal Lobe, MRI Scans
- Being tested
- MRI
- Keywords
- structural connectivity, insula, temporal lobe epilepsy
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
structural imaging
| Study group | Role | What they receive |
|---|---|---|
| mesio-temporal epilepsy | patients suffering from mesiotemporal epilepsy type Receives: Other: MRI | |
| basal temporal epilepsy | patients suffering from basal temporal epilepsy type Receives: Other: MRI | |
| temporal lateral epilepsy | patients suffering from temporal lateral epilepsy type Receives: Other: MRI | |
| operculo insular epilepsy | patients suffering from operculo insular epilepsy type Receives: Other: MRI | |
| temporo-insular epilepsy | patients suffering from temporo- insular epilepsy type Receives: Other: MRI | |
| healthy subjects | non epileptic patients Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
cartography of insula in temporal epilepsy patients
Compared with healthy group, definition of different patterns of insular structural connectivity in epileptic patients
Measured: 1 year after the last inclusion
Secondary outcomes (1)
Correlation structural cartography and electroclinical data
correlation between patterns of insular structural connectivity and subtypes of epilepsy defined by electroclinical data
Measured: 1 year after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, University Hospital, Lille, Hospices Civils de Lyon
- Responsible party
- Principal investigator, TYVAERT Louise, Central Hospital, Nancy, France
- Investigators
- Louise Tyvaert, MD PHD, Principal investigator, CHRU Nancy, CRAN UMR 7039 Université de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871555
- Sponsor's protocol ID
- 2020PI218
- Acronym
- CON-INSULA
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Cartography of the Insula in Temporal Epilepsy Patients
- ClinicalTrials.gov ID
- NCT04871555
- Acronym / sponsor ID
- CON-INSULA / 2020PI218
- Conditions
- Epilepsy, Temporal Lobe, MRI Scans
- Keywords
- structural connectivity, insula, temporal lobe epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, University Hospital, Lille, Hospices Civils de Lyon
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 May 2021 (actual)
- 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.
The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.
Detailed description
The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| mesio-temporal epilepsy | – | Other: MRIpatients suffering from mesiotemporal epilepsy type |
| basal temporal epilepsy | – | Other: MRIpatients suffering from basal temporal epilepsy type |
| temporal lateral epilepsy | – | Other: MRIpatients suffering from temporal lateral epilepsy type |
| operculo insular epilepsy | – | Other: MRIpatients suffering from operculo insular epilepsy type |
| temporo-insular epilepsy | – | Other: MRIpatients suffering from temporo- insular epilepsy type |
| healthy subjects | – | Other: MRInon epileptic patients |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- temporal epilepsy patients and healthy subjects healthy subjects will be selected in the healthy cohort of Nguyen G-Dang (Ghaziri et al., 2017)
Key inclusion criteria (4 listed)
- epileptic patients: temporal epilepsy or temporal plus epilepsy (temporomesial epilepsy, basal temporal epilepsy, mesio lateral or lateral epilepsy, temporo insular epilepsy, operculo insular epilepsy)
- patients who underwent video EEG monitoring with recorded seizures (at least one)
- patients who underwent a brain MRI with DTI sequence before epilepsy surgery
- patients who did not refuse the use of their clinical and MRI data for this study
Key exclusion criteria (3 listed)
- patients younger than 15 years old
- patients with previous brain surgery (before MRI)
- uncompleted MRI sequences (DTI, T1 anatomical)
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 |
|---|---|---|
| MRIstructural imaging | Other | basal temporal epilepsy, healthy subjects, mesio-temporal epilepsy, operculo insular epilepsy, temporal lateral epilepsy, temporo-insular epilepsy |
Primary outcome
cartography of insula in temporal epilepsy patients
Time frame: 1 year after the last inclusion
Compared with healthy group, definition of different patterns of insular structural connectivity in epileptic patients
1 secondary outcome
Correlation structural cartography and electroclinical data
Time frame: 1 year after the last inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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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.
Louise Tyvaert, MD PHD principal investigator
CHRU Nancy, CRAN UMR 7039 Université de Lorraine
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 Epilepsy, Temporal Lobe and MRI Scans, run by Central Hospital, Nancy, France 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 4 inclusion and 3 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 4 May 2021. 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 Louise Tyvaert, Pr (33383857723, l.tyvaert@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cartography of insula in temporal epilepsy patients (time frame: 1 year after the last inclusion). 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 4 May 2021.