EpilepsyRESPIRENCT04451278
RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Epilepsy
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2020to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from 6 to 18 years old receiving an MRI as part of a preoperative assessment of lesion epilepsy
Who may be able to join
- Patient aged between 6 and 18 years
- Receiving an MRI for lesional drug-resistant epilepsy
- Affiliated or beneficiary of a social security plan
- Whose parents or guardians have received information about the study and have given their express consent to participate in the study
Who cannot join
- Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding women)
- History of intracranial surgery
- MRI performed under general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation A De Rothschild
Paris, PARIS, 75019
Amelie YAVCHITZ, 0148036431, ayavchitz@for.paris
Sidney KRYSTAL
About this study
Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness.
To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resting-state functional MRI (r-fMRI) | The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional fMRI-r sequence, called resting state, and performed before injection of gadoline contrast. A neuropsychological evaluation is performed as part of the 6 months prior to the procedure. These data will be used as a basis for the evaluation of language visual and language recovery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.
The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Oct 2020
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sidney KRYSTAL, Principal investigator, Adolphe de Rothschild Fondation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451278
- Sponsor's protocol ID
- 2020-A01561-38
- Acronym
- RESPIRE
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2020
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT04451278
- Acronym / sponsor ID
- RESPIRE / 2020-A01561-38
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Jun 2020 (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.
Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness.
To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resting-state functional MRI (r-fMRI) | – | –The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional fMRI-r sequence, called resting state, and performed before injection of gadoline contrast. A neuropsychological evaluation is performed as part of the 6 months prior to the procedure. These data will be used as a basis for the evaluation of language visual and language recovery. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from 6 to 18 years old receiving an MRI as part of a preoperative assessment of lesion epilepsy
Key inclusion criteria (4 listed)
- Patient aged between 6 and 18 years
- Receiving an MRI for lesional drug-resistant epilepsy
- Affiliated or beneficiary of a social security plan
- Whose parents or guardians have received information about the study and have given their express consent to participate in the study
Key exclusion criteria (3 listed)
- Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding women)
- History of intracranial surgery
- MRI performed under general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.
Time frame: One year
The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Sidney KRYSTAL principal investigator
Adolphe de Rothschild Fondation Hospital
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, run by Fondation Ophtalmologique Adolphe de Rothschild 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sidney KRYSTAL (01 48 03 65 65 ext. + 33, skrystal@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy. (time frame: One year). 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 5 Jan 2026.