Refractory EpilepsySPREADNCT03321240
Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
An observational study of Refractory Epilepsy and Focal Epilepsy, run by University Hospital, Strasbourg, France at 11 sites in France.
Trial summary
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Refractory Epilepsy, Focal Epilepsy, Focal Cortical Dysplasia
- What is being tested?
- visual and quantitative SEEG signal analysis and Resective epilepsy surgery procedure
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Jan 2018to 15 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult or pediatric (Age more than 2 years old) patients attending tertiary epilepsy center for presurgical evaluation of refractory focal epilepsy compatible with FCD
Who may be able to join
- Adult or pediatric patient suffering from drug-resistant focal epilepsy;
- Age more than 2 years old;
- Brain MRI suggestive of FCD or normal;
- Standardized presurgical evaluation available including medical history, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests;
- Inpatient in one of the participating centers for recording seizure during long term scalp video-EEG and / or SEEG-monitoring;
- Resective surgery with a minimal post-operative follow-up of 12 months;
- Histopathologic evidence for FCD or non-pathologic findings (normal histology or mMCD type II).
- Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures.
Who cannot join
- Brain MRI suggestive of another type of lesion;
- Difficulty to read or understand French, or inability to understand the information;
- Pregnant or breastfeeding woman;
- Subject under judicial protection.
- Other lesion discovered on histological examination;
- FCD type 3, dual pathology, ambiguous or unavailable neuropathological findings
- Lack of longitudinal pre- and post-surgical follow-up.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Michallon Hospital
Grenoble, 38043
Philippe KAHANE, +33 4 76 76 54 48, philippe.kahane@univ-grenoble-alpes.fr
- Recruiting
Hôpital Roger Salengro
Lille, 59037
William SZURHAJ, +33 3 20 44 63 73, william.szurhaj@chru-lille.fr
- Recruiting
Hospices Civils de Lyon
Lyon, 69001
Sylvain RHEIMS, +33 4 72 3570 44, sylvain.rheims@chu-lyon.fr
- Recruiting
Timone Hospital
Marseille, 13005
Fabrice BARTOLOMEI, +33 4 91 38 49 90, fabrice.bartolomei@ap-hm.fr
- Recruiting
University Hospital of Nancy
Nancy, 54000
Louis MAILLARD, +33 3 83 85 23 79, l.maillard@chru-nancy.fr
- Recruiting
GH Pitie-Salpêtrière-Charles Foix
Paris, 75013
Vincent NAVARRO, +33 1 42 16 18 13, vincent.navarro@aphp.fr
- Recruiting
Necker-Enfants Malades Hospital
Paris, 75015
KAMINSKA Anna, +33 1 44 45 18 50, anna.kaminska@nck.aphp.fr
- Recruiting
Rothschild Foundation
Paris, 75019
Mathilde CHIPAUX, MD, +33 1 48 03 69 43, mchipaux@for.paris
- Recruiting
CHU Rennes
Rennes, 35000
Anca NICA, +33 2 99 28 43 21, Anca.NICA@chu-rennes.fr
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Edouard HIRSCH, +33 3 88 12 85 62, edouard.hirsch@chru-strasbourg.fr
Julia SCHOLLY, +33 3 88 12 85 78, julia.scholly@chru-strasbourg.fr
- Recruiting
Hôpital Pierre Paul Riquet
Toulouse, 31059
Luc VALTON, +33 5 61 77 94 88, valton.l@chu-toulouse.fr
About this study
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.
- Being tested
- visual and quantitative SEEG signal analysis, Resective epilepsy surgery procedure
- Keywords
- focal cortical dysplasia, Pronostic, Epilepsy surgery, Epiletogenicity index, SEEG
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsies, Partial, Focal Cortical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual and quantitative SEEG signal analysisProcedure or surgery
signal SEEG analysis
Resective epilepsy surgery procedureProcedure or surgery
Surgical removal of the epileptogenic brain area
| Study group | Role | What they receive |
|---|---|---|
| The SEEG group | Group with the SEEG analysis Receives: Procedure: visual and quantitative SEEG signal analysis; Procedure: Resective epilepsy surgery procedure | |
| The direct surgery group | Group with a direct surgery Receives: Procedure: Resective epilepsy surgery procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.
Measured: 12 month
Secondary outcomes (3)
Proportion of each of six seizure-onset pattern types within each of three histologically defined subgroups (FCD type I, FCD type II, non-pathologic findings).
Measured: 12 month
Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI)
Measured: 12 month
Topographic distribution of structures that disclose high Epileptogenicity Index values (EI>0.4), of structures with maximal interictal HFO rates and of structures showing interictal/preictal functional connectivity alterations
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start15 Jan 2018
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321240
- Sponsor's protocol ID
- 6647
- Acronym
- SPREAD
- Status last verified
- Jun 2019
- First submitted
- 16 Oct 2017
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
- ClinicalTrials.gov ID
- NCT03321240
- Acronym / sponsor ID
- SPREAD / 6647
- Keywords
- focal cortical dysplasia, Pronostic, Epilepsy surgery, Epiletogenicity index, SEEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 25 Oct 2017 (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.
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The SEEG group | – | Procedure: visual and quantitative SEEG signal analysis, Procedure: Resective epilepsy surgery procedureGroup with the SEEG analysis |
| The direct surgery group | – | Procedure: Resective epilepsy surgery procedureGroup with a direct surgery |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult or pediatric (Age more than 2 years old) patients attending tertiary epilepsy center for presurgical evaluation of refractory focal epilepsy compatible with FCD
Key inclusion criteria (8 listed)
- Adult or pediatric patient suffering from drug-resistant focal epilepsy;
- Age more than 2 years old;
- Brain MRI suggestive of FCD or normal;
- Standardized presurgical evaluation available including medical history, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests;
- Inpatient in one of the participating centers for recording seizure during long term scalp video-EEG and / or SEEG-monitoring;
Key exclusion criteria (7 listed)
- Brain MRI suggestive of another type of lesion;
- Difficulty to read or understand French, or inability to understand the information;
- Pregnant or breastfeeding woman;
- Subject under judicial protection.
- Other lesion discovered on histological examination;
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 |
|---|---|---|
| visual and quantitative SEEG signal analysissignal SEEG analysis | Procedure or surgery | The SEEG group |
| Resective epilepsy surgery procedureSurgical removal of the epileptogenic brain area | Procedure or surgery | The SEEG group, The direct surgery group |
Primary outcome
Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.
Time frame: 12 month
3 secondary outcomes
Proportion of each of six seizure-onset pattern types within each of three histologically defined subgroups (FCD type I, FCD type II, non-pathologic findings).
Time frame: 12 month
Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI)
Time frame: 12 month
Topographic distribution of structures that disclose high Epileptogenicity Index values (EI>0.4), of structures with maximal interictal HFO rates and of structures showing interictal/preictal functional connectivity alterations
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Epilepsy and Focal Epilepsy, run by University Hospital, Strasbourg, France at 11 sites 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 8 inclusion and 7 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 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Edouard HIRSCH (+33 3 88 12 85 62, edouard.hirsch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery. (time frame: 12 month). 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 24 Jun 2019.