EpilepsyNCT06210022
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
An observational study of Epilepsy and Focal Epilepsy, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study. Patients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy, Focal Epilepsy
- What is being tested?
- Neuropsychological Assessment
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2024to 1 Mar 2027
- How long will I take part?
- 12 Months
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with diagnosis of DRE and DSE will be recruited among patients who are regularly followed at our Epilepsy Outpatients Service (OSR). The diagnosis of DRE and DSE focal cryptogenic epilepsy will be based on the most recent sets of criteria of different types of epilepsy. A small group of NDE patients will be also enrolled.
Who may be able to join
- monolingual native Italian speakers;
- age between 18-60 years;
- normal or corrected-to-normal visual acuity;
- oral and written informed consent to study participation.
- if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks.
- diagnosis of focal cryptogenic epilepsy;
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- previous failure of at least 2 anti-seizure medication (ASM at adequate dose;
- at least 3 seizures in the last 2 months; • available brain MRI (<5 years).
- diagnosis of focal cryptogenic epilepsy;
- seizure control obtained after not more than 2 ASM;
- seizure freedom for at least 6 months;
- available brain MRI (<5 years).
- new diagnosis of focal cryptogenic epilepsy (<3 months)
- not more than 1 ASM tested
- available brain MRI (<3 months)
Who cannot join
- Age> 60 years;
- Documented developmental delay;
- Evidence of focal abnormalities at neuroimaging (except of hippocampal sclerosis);
- Neurological degenerative conditions;
- history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
- alcohol and/or psychotropic drugs abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, 20132
Massimo Filippi, MD, 00390226433054, filippi.massimo@hsr.it
Anna A. Bellini, MD, 00390226432154, bellini.anna@hsr.it
About this study
Official title: Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study
This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study.
Patients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32channel EEG at baseline (T0). DRE patients will also undergo clinical and cognitive assessments, and 32-channel EEG at 6 months (T1), and 12 months (T2). Patients newly diagnosed with focal cryptogenic epilepsy (NDE) will undergo clinical and cognitive assessments, and 32-channel EEG at baseline (T0), at 6 months (T1), and 12 months (T2).
Read more
High-definition EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration specific to DRE and DSE and to explore their prognostic value. Longitudinal EEGs will be acquired to explore the evolution of EEG patterns.
Cognitive evaluation will be performed by an experienced neuropsychologist. At baseline, DRE, DSE, and NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The DRE and NDE group only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and/or behavioural disturbances in these patients.
Read the detailed description
At the study entry (T0) DSE, DRE, and NDE will undergo cognitive evaluations (investigating the main cognitive domains), neurological examinations, and 32channel EEG. DRE and NDE patients will undergo the same clinical, cognitive and 32-channel EEG evaluations at T1 (6 months) and T2 (12 months). DSE patients will be tested only at baseline and they will not undergo longitudinal evaluations.
ASM therapy and seizure frequency will be recorded for DRE and NDE patients in a dedicated database at T0, T1 and T2 High-density EEGs, with a duration of 20 minutes, will be acquired in resting awake conditions on a computer-based system (Micromed System PLUS, Micromed S.p.A., Mogliano Veneto, Italy) from 32 surface electrodes, placed on an EEG cap according to the international 10/20 system, with linked-ear or mesial prefrontal reference. Vigilance will be continuously monitored in order to avoid drowsiness. The quality of sleep during the night previous to the exam will be investigated by the recording technician. Standard clinical procedures will be implemented in the acquisition protocol.
Cognitive evaluations will be performed by an experienced neuropsychologist. The following domains will be assessed: global cognition, memory, language, attention, executive functions, visuospatial abilities, mood and behavior. Moreover, for the assessment of quality of life, the 12-item Short Form Survey (SF-12) will be administered to DSE patients at baseline, and to NDE patients and DRE at baseline and at the follow-up.
Clinical and cognitive data will be exported and analyzed through SPSS and/or R software afterwards. All demographic, personal and clinical information will be codified.
EEG will be stored in a digital archive and on CDs, and then uploaded on dedicated PCs and Linux stations in order to perform the analyses
- Conditions
- Epilepsy, Focal Epilepsy
- Being tested
- Neuropsychological Assessment
- Keywords
- epilepsy, focal cryptogenic epilepsy, drug resistant epilepsy
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological AssessmentDiagnostic test
Cognitive evaluation and clinical monitoring of seizure frequency
| Study group | Role | What they receive |
|---|---|---|
| 130 | Patients with diagnosis of DRE and DSE will be recruited among patients who are regularly followed at our Epilepsy Outpatients Service (OSR). The diagnosis of DRE and DSE focal cryptogenic epilepsy will be based on the most recent sets of criteria of different types of epilepsy. A small group of NDE patients will be also enrolled
A population of 30 focal cryptogenic epilepsy patients diagnosed with DRE (drug resistant epilepsy) A population of 90 focal cryptogenic epilepsy patients diagnosed with DRE (drug sensitive epilepsy) 10 patients newly diagnosed for focal cryptogenic epilepsy (NDE) will be recruited too. Receives: Diagnostic Test: Neuropsychological Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of cognitive impairment in a population of focal cryptogenic epilepsy patients, comparing subjects diagnosed with DRE (drug resistant epilepsy) and subjects diagnosed with DSE (drug sensitive epilepsy);
At baseline, DRE and DSE patients will undergo a screening and comprehensive cognitive battery. We will adopt the following scales: EpiTrack screening battery; Rey Auditory Verbal Learning Test and with the Rey's figure recall; Token Test; Paced Auditory Serial Addition Test; Modified Card Sorting Test; Cognitive Estimation Task; Rey's figure copy, Beck Depression Inventory, Dimensional Apathy Scale, 12-item Short Form Survey. The suspect of cognitive impairment (CI) will be defined with EpiTrack screening battery (score < 32 points indicates CI). This will be confirmed by the comprehensive battery (Level II): Impairment should be present on at least 2 tests. For each test, impairment will be demonstrated with performances below appropriate normative values. Since the classification for CI is not yet defined for epilepsy we will adopt the classification for Parkinson's disease which, as patients with epilepsy, mainly have disturbances in executive, attentive and memory functioning.
Measured: 2024-2027
To monitor the evolution of cognitive performance in DRE patients over a period of one year;
we evaluate the cognitive state of the patients with the measures and scales listed in "Outcome 1" at 12 months and compare the results to the baseline results.
Measured: 2024-2027
To evaluate whether seizure frequency constitute the main determinant of cognitive impairment;
We evaluate if patients who reduced the seizure frequence over a period of 12 months showed an improvement in the cognitive assesment, comparing baseline assesment and the follow up assesment at 12 months.
Measured: 2024-2027
To explore EEG-markers of DRE and DSE
High-density EEGs, with a duration of 20 minutes, will be acquired in resting awake conditions on a computer-based system (Micromed System PLUS, Micromed S.p.A., Mogliano Veneto, Italy) from 32 surface electrodes, placed on an EEG cap according to the international 10/20 system, with linked-ear or mesial prefrontal reference. Vigilance will be continuously monitored in order to avoid drowsiness.
EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration in the two different groups od DRE and DSE.
Measured: 2024-2027
To evaluate the entity of cognitive impairment in a population of focal cryptogenic epilepsy patients, comparing subjects diagnosed with DRE (drug resistant epilepsy) and subjects diagnosed with DSE (drug sensitive epilepsy);
To evaluate the entity of cognitive impairment in DSE with the measures and methods specified in "Outcome 1".
Measured: 2024-2027
To evaluate whether ASM therapy constitute the main determinant of cognitive impairment;
We evaluate if patients who reduced the number of ASMs medications over a period of 12 months showed an improvement in the cognitive assesment, comparing baseline assesment and the follow up assesment at 12 months.
Measured: 2024-2027
To explore a possible relationship between EEG-markers of DRE and DSE and cognitive impairment
To explore a possible relationship between EEG-markers of DRE and DSE found as specified in "Outcome 4" and cognitive impairment (evaluated as specified in "Outcome 1").
Measured: 2024-2027
Secondary outcomes (2)
To evaluate longitudinal evolution of cognitive performances in patients newly diagnosed with focal cryptogenic epilepsy (NDE)
At baseline, NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The NDE patients groups only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and/or behavioral disturbances in these patients.
We will use the same neuropsychological scales listed in "Outcome 1".
Measured: 2024-2027
To evaluate longitudinal evolution of drug responsiveness in patients newly diagnosed with focal cryptogenic epilepsy (NDE)
We evaluate if over a period of 6 and 12 months the patients of NDE groups have showed drug responsiveness, assessed as "reduction of number of seizure per month", compared to the baseline data.
Measured: 2024-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 Jun 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (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 IRCCS San RaffaeleThe 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
- 130 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210022
- Sponsor's protocol ID
- FCECOG
- Status last verified
- Jun 2024
- First submitted
- 21 Dec 2023
- Last updated
- 24 Jun 2024
- Results posted
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT06210022
- Acronym / sponsor ID
- FCECOG
- Conditions
- Epilepsy, Focal Epilepsy
- Keywords
- epilepsy, focal cryptogenic epilepsy, drug resistant epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Jan 2024 (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.
This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study.
Patients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32channel EEG at baseline (T0). DRE patients will also undergo clinical and cognitive assessments, and 32-channel EEG at 6 months (T1), and 12 months (T2). Patients newly diagnosed with focal cryptogenic epilepsy (NDE) will undergo clinical and cognitive assessments, and 32-channel EEG at baseline (T0), at 6 months (T1), and 12 months (T2).
High-definition EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration specific to DRE and DSE and to explore their prognostic value. Longitudinal EEGs will be acquired to explore the evolution of EEG patterns.
Cognitive evaluation will be performed by an experienced neuropsychologist. At baseline, DRE, DSE, and NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The DRE and NDE group only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and/or behavioural disturbances in these patients.
Detailed description
At the study entry (T0) DSE, DRE, and NDE will undergo cognitive evaluations (investigating the main cognitive domains), neurological examinations, and 32channel EEG. DRE and NDE patients will undergo the same clinical, cognitive and 32-channel EEG evaluations at T1 (6 months) and T2 (12 months). DSE patients will be tested only at baseline and they will not undergo longitudinal evaluations.
ASM therapy and seizure frequency will be recorded for DRE and NDE patients in a dedicated database at T0, T1 and T2 High-density EEGs, with a duration of 20 minutes, will be acquired in resting awake conditions on a computer-based system (Micromed System PLUS, Micromed S.p.A., Mogliano Veneto, Italy) from 32 surface electrodes, placed on an EEG cap according to the international 10/20 system, with linked-ear or mesial prefrontal reference. Vigilance will be continuously monitored in order to avoid drowsiness. The quality of sleep during the night previous to the exam will be investigated by the recording technician. Standard clinical procedures will be implemented in the acquisition protocol.
Cognitive evaluations will be performed by an experienced neuropsychologist. The following domains will be assessed: global cognition, memory, language, attention, executive functions, visuospatial abilities, mood and behavior. Moreover, for the assessment of quality of life, the 12-item Short Form Survey (SF-12) will be administered to DSE patients at baseline, and to NDE patients and DRE at baseline and at the follow-up.
Clinical and cognitive data will be exported and analyzed through SPSS and/or R software afterwards. All demographic, personal and clinical information will be codified.
EEG will be stored in a digital archive and on CDs, and then uploaded on dedicated PCs and Linux stations in order to perform the analyses
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 130 | – | Diagnostic Test: Neuropsychological AssessmentPatients with diagnosis of DRE and DSE will be recruited among patients who are regularly followed at our Epilepsy Outpatients Service (OSR). The diagnosis of DRE and DSE focal cryptogenic epilepsy will be based on the most recent sets of criteria of different types of epilepsy. A small group of NDE patients will be also enrolled A population of 30 focal cryptogenic epilepsy patients diagnosed with DRE (drug resistant epilepsy) A population of 90 focal cryptogenic epilepsy patients diagnosed with DRE (drug sensitive epilepsy) 10 patients newly diagnosed for focal cryptogenic epilepsy (NDE) will be recruited too. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with diagnosis of DRE and DSE will be recruited among patients who are regularly followed at our Epilepsy Outpatients Service (OSR). The diagnosis of DRE and DSE focal cryptogenic epilepsy will be based on the most recent sets of criteria of different types of epilepsy. A small group of NDE patients will be also enrolled.
Key inclusion criteria (15 listed)
Key exclusion criteria (6 listed)
- Age> 60 years;
- Documented developmental delay;
- Evidence of focal abnormalities at neuroimaging (except of hippocampal sclerosis);
- Neurological degenerative conditions;
- history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
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 |
|---|---|---|
| Neuropsychological AssessmentCognitive evaluation and clinical monitoring of seizure frequency | Diagnostic test | 130 |
Primary outcome
To evaluate the prevalence of cognitive impairment in a population of focal cryptogenic epilepsy patients, comparing subjects diagnosed with DRE (drug resistant epilepsy) and subjects diagnosed with DSE (drug sensitive epilepsy);
Time frame: 2024-2027
At baseline, DRE and DSE patients will undergo a screening and comprehensive cognitive battery. We will adopt the following scales: EpiTrack screening battery; Rey Auditory Verbal Learning Test and with the Rey's figure recall; Token Test; Paced Auditory Serial Addition Test; Modified Card Sorting Test; Cognitive Estimation Task; Rey's figure copy, Beck Depression Inventory, Dimensional Apathy Scale, 12-item Short Form Survey. The suspect of cognitive impairment (CI) will be defined with EpiTrack screening battery (score < 32 points indicates CI). This will be confirmed by the comprehensive battery (Level II): Impairment should be present on at least 2 tests. For each test, impairment will be demonstrated with performances below appropriate normative values. Since the classification for CI is not yet defined for epilepsy we will adopt the classification for Parkinson's disease which, as patients with epilepsy, mainly have disturbances in executive, attentive and memory functioning.
To monitor the evolution of cognitive performance in DRE patients over a period of one year;
Time frame: 2024-2027
we evaluate the cognitive state of the patients with the measures and scales listed in "Outcome 1" at 12 months and compare the results to the baseline results.
To evaluate whether seizure frequency constitute the main determinant of cognitive impairment;
Time frame: 2024-2027
We evaluate if patients who reduced the seizure frequence over a period of 12 months showed an improvement in the cognitive assesment, comparing baseline assesment and the follow up assesment at 12 months.
To explore EEG-markers of DRE and DSE
Time frame: 2024-2027
High-density EEGs, with a duration of 20 minutes, will be acquired in resting awake conditions on a computer-based system (Micromed System PLUS, Micromed S.p.A., Mogliano Veneto, Italy) from 32 surface electrodes, placed on an EEG cap according to the international 10/20 system, with linked-ear or mesial prefrontal reference. Vigilance will be continuously monitored in order to avoid drowsiness. EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration in the two different groups od DRE and DSE.
To evaluate the entity of cognitive impairment in a population of focal cryptogenic epilepsy patients, comparing subjects diagnosed with DRE (drug resistant epilepsy) and subjects diagnosed with DSE (drug sensitive epilepsy);
Time frame: 2024-2027
To evaluate the entity of cognitive impairment in DSE with the measures and methods specified in "Outcome 1".
To evaluate whether ASM therapy constitute the main determinant of cognitive impairment;
Time frame: 2024-2027
We evaluate if patients who reduced the number of ASMs medications over a period of 12 months showed an improvement in the cognitive assesment, comparing baseline assesment and the follow up assesment at 12 months.
To explore a possible relationship between EEG-markers of DRE and DSE and cognitive impairment
Time frame: 2024-2027
To explore a possible relationship between EEG-markers of DRE and DSE found as specified in "Outcome 4" and cognitive impairment (evaluated as specified in "Outcome 1").
2 secondary outcomes
To evaluate longitudinal evolution of cognitive performances in patients newly diagnosed with focal cryptogenic epilepsy (NDE)
Time frame: 2024-2027
To evaluate longitudinal evolution of drug responsiveness in patients newly diagnosed with focal cryptogenic epilepsy (NDE)
Time frame: 2024-2027
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 24 Jun 2024.
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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.
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 and Focal Epilepsy, run by IRCCS San Raffaele at 1 site in Italy.
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 15 inclusion and 6 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 24 Jun 2024. 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 Italy. 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 Anna Bellini, MD (+390226432154, bellini.anna@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the prevalence of cognitive impairment in a population of focal cryptogenic epilepsy patients, comparing subjects diagnosed with DRE (drug resistant epilepsy) and subjects diagnosed with DSE (drug sensitive epilepsy); (time frame: 2024-2027). The study lists 7 primary outcomes in all. 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 2024.