BECTSBECTSNCT03465566
Emotion Recognition in Benign Epilepsy of Childhood With Centro-Temporal Spikes (BECTS)
An observational study of BECTS and Epilepsy, Rolandic, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
The social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- BECTS, Epilepsy, Rolandic
- What is being tested?
- IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 1 Mar 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Two samples matched for number of partecipants, sex, age range, and education. The two samples will include 200 children with BECTS diagnosis, as many healthy controls.
Who may be able to join
- children diagnosed with active BECTS (e.g. having at least one seizure with epileptiform abnormalities at EEG)
- treated or not with anti-epileptic drugs; age range between 6 and 11
- infants who have not presented an epileptic seizure within 48 hours before the psychodiagnostic evaluation
- patients with a sleep EEG recording; MMSPE (Mini Mental State Pediatric Examination) ≥23.3
Who cannot join
- mental retardation
- presence of other neurological or severe neuropsychiatric disorders
- atypical EEG pattern (awake or asleep)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facial Emotion Decoding in Benign Partial Epilepsy of Childhood With Centrotemporal Spikes
The social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. Accordingly, children with early onset temporal lobe epilepsy (TLE) demonstrate altered emotion recognition.
Read the detailed description
Study design: Multicentre, Case-control study.
Emotion recognition is a first step for the development of the capacity to judge the thoughts, intentions, and desires of others. In infants, the capacity to identify, distinguish, and interpret emotions is limited, but these processes are developing rapidly and innately during the first years of life, on the same neural bases as those described in adulthood. Children with BECTS show altered social behavior. In fact, deficit in social cognition could derive from brain dysfunction in the frontotemporal regions primarily affected in BECTS, since these regions are also viewed as playing an important role in social cognition and development of social skills.
The investigators hypothesized that children with BECTS might have altered social cognitive skills and underlying neural networks.
- Conditions
- BECTS, Epilepsy, Rolandic
- Being tested
- IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation
- Keywords
- Emotion, Social cognition, Childhood epilepsy
- Medical subject headings
- Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluationDiagnostic test
Five pictures (including nonfacial features; i.e., hairs) were used for each emotion, giving a total of 25 trials.Stimuli consist of pictures of facial affect taken from the Ekman and Friesen series.
| Study group | Role | What they receive |
|---|---|---|
| Children with BECTS | Children with active BECTS according to state-of-the-art diagnostic criteria of ILAE (International League Against Epilepsy). Eligible subjects will be recruited at their first clinical observation in the epilepsy centers involved in the study.
All subjects will perform five diagnostic evaluations named:
IDS (Intelligence and Development Scale) MMSPE (Mini Mental State Pediatric Examination) CDI 2 (Children Depression Inventory 2) CBCL (Child Behavior Check List) Tests of facial expression evaluation Receives: Diagnostic Test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation | |
| Healthy children | Healthy controls matched for sex, age range, and education with no family history for epilepsy or other neuropsychiatric disorders.
All subjects will perform the following tests:
MMSPE (Mini Mental State Pediatric Examination) CDI 2 (Children Depression Inventory 2) CBCL (Child Behavior Check List) Tests of facial expression evaluation Receives: Diagnostic Test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (total amount) of errors in facial emotion recognition
A neuropsychologist will sign the number of errors in recognizing each facial emotion expression
Measured: an average of 1 year
Rating of the intensity of facial expressions
A neuropsychologist will ask the subjects to rate (on a scale from 0 = not at all to 5 = very much) each stimulus with respect to the prototypical expression of that emotion
Measured: an average of 1 year
Rating of the arousal of facial expressions
A neuropsychologist will ask the subjects to evaluate arousal in terms of feeling of high-low energy/wakefulness/alertness by rating each stimulus on a 9-point scale.
Measured: an average of 1 year
Rating of the valence of facial expressions
A neuropsychologist will ask the subjects to evaluate valence in terms of feeling of high-low pleasantness-unpleasantness by rating each stimulus on a 9-point scale.
Measured: an average of 1 year
Secondary outcomes (1)
EEG abnormality lateralization and facial emotion recognition
The investigators will include in statistical analysis the side (dominant hemisphere vs. non-dominant) of EEGraphic abnormalities on awake/sleep recordings
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BECTSStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo D'Aniello, Neuromed IRCCS
- Investigators
- Giancarlo Di Gennaro, MD, PhD, Study director, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465566
- Sponsor's protocol ID
- DGN01
- Acronym
- BECTS
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Risi M, Di Gennaro G, Picardi A, Casciato S, Grammaldo LG, D'Aniello A, Lanni D, Meletti S, Modugno N. Facial emotion decoding in patients with Parkinson's disease. Int J Neurosci. 2018 Jan;128(1):71-78. doi: 10.1080/00207454.2017.1366475. Epub 2017 Aug 28.
PubMed 28796560Meletti S, Picardi A, De Risi M, Monti G, Esposito V, Grammaldo LG, Di Gennaro G. The affective value of faces in patients achieving long-term seizure freedom after temporal lobectomy. Epilepsy Behav. 2014 Jul;36:97-101. doi: 10.1016/j.yebeh.2014.05.002. Epub 2014 Jun 2.
PubMed 24892756
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Emotion Decoding in Benign Partial Epilepsy of Childhood With Centrotemporal Spikes
- ClinicalTrials.gov ID
- NCT03465566
- Acronym / sponsor ID
- BECTS / DGN01
- Conditions
- BECTS, Epilepsy, Rolandic
- Keywords
- Emotion, Social cognition, Childhood epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 14 Mar 2018 (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 social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. Accordingly, children with early onset temporal lobe epilepsy (TLE) demonstrate altered emotion recognition.
Detailed description
Study design: Multicentre, Case-control study.
Emotion recognition is a first step for the development of the capacity to judge the thoughts, intentions, and desires of others. In infants, the capacity to identify, distinguish, and interpret emotions is limited, but these processes are developing rapidly and innately during the first years of life, on the same neural bases as those described in adulthood. Children with BECTS show altered social behavior. In fact, deficit in social cognition could derive from brain dysfunction in the frontotemporal regions primarily affected in BECTS, since these regions are also viewed as playing an important role in social cognition and development of social skills.
The investigators hypothesized that children with BECTS might have altered social cognitive skills and underlying neural networks.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with BECTS | – | Diagnostic Test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluationChildren with active BECTS according to state-of-the-art diagnostic criteria of ILAE (International League Against Epilepsy). Eligible subjects will be recruited at their first clinical observation in the epilepsy centers involved in the study. All subjects will perform five diagnostic evaluations named: IDS (Intelligence and Development Scale) MMSPE (Mini Mental State Pediatric Examination) CDI 2 (Children Depression Inventory 2) CBCL (Child Behavior Check List) Tests of facial expression evaluation |
| Healthy children | – | Diagnostic Test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluationHealthy controls matched for sex, age range, and education with no family history for epilepsy or other neuropsychiatric disorders. All subjects will perform the following tests: MMSPE (Mini Mental State Pediatric Examination) CDI 2 (Children Depression Inventory 2) CBCL (Child Behavior Check List) Tests of facial expression evaluation |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Two samples matched for number of partecipants, sex, age range, and education. The two samples will include 200 children with BECTS diagnosis, as many healthy controls.
Key inclusion criteria (4 listed)
- children diagnosed with active BECTS (e.g. having at least one seizure with epileptiform abnormalities at EEG)
- treated or not with anti-epileptic drugs; age range between 6 and 11
- infants who have not presented an epileptic seizure within 48 hours before the psychodiagnostic evaluation
- patients with a sleep EEG recording; MMSPE (Mini Mental State Pediatric Examination) ≥23.3
Key exclusion criteria (3 listed)
- mental retardation
- presence of other neurological or severe neuropsychiatric disorders
- atypical EEG pattern (awake or asleep)
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 |
|---|---|---|
| IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluationFive pictures (including nonfacial features; i.e., hairs) were used for each emotion, giving a total of 25 trials.Stimuli consist of pictures of facial affect taken from the Ekman and Friesen series. | Diagnostic test | Children with BECTS, Healthy children |
Primary outcome
Number (total amount) of errors in facial emotion recognition
Time frame: an average of 1 year
A neuropsychologist will sign the number of errors in recognizing each facial emotion expression
Rating of the intensity of facial expressions
Time frame: an average of 1 year
A neuropsychologist will ask the subjects to rate (on a scale from 0 = not at all to 5 = very much) each stimulus with respect to the prototypical expression of that emotion
Rating of the arousal of facial expressions
Time frame: an average of 1 year
A neuropsychologist will ask the subjects to evaluate arousal in terms of feeling of high-low energy/wakefulness/alertness by rating each stimulus on a 9-point scale.
Rating of the valence of facial expressions
Time frame: an average of 1 year
A neuropsychologist will ask the subjects to evaluate valence in terms of feeling of high-low pleasantness-unpleasantness by rating each stimulus on a 9-point scale.
1 secondary outcome
EEG abnormality lateralization and facial emotion recognition
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Background: PubMed 28796560De Risi M, Di Gennaro G, Picardi A, Casciato S, Grammaldo LG, D'Aniello A, Lanni D, Meletti S, Modugno N. Facial emotion decoding in patients with Parkinson's disease. Int J Neurosci. 2018 Jan;128(1):71-78. doi: 10.1080/00207454.2017.1366475. Epub 2017 Aug 28.
- Background: PubMed 24892756Meletti S, Picardi A, De Risi M, Monti G, Esposito V, Grammaldo LG, Di Gennaro G. The affective value of faces in patients achieving long-term seizure freedom after temporal lobectomy. Epilepsy Behav. 2014 Jul;36:97-101. doi: 10.1016/j.yebeh.2014.05.002. Epub 2014 Jun 2.
Related trials for BECTS
Recruiting
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Benign Epilepsy With Centro Temporal Spikes (BECTS), Atypical Benign Partial Epilepsy (ABPE)
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.
Giancarlo Di Gennaro, MD, PhD study director
IRCCS Neuromed
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 BECTS and Epilepsy, Rolandic, run by Neuromed IRCCS 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 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 2 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfredo D'Aniello, MD (0039865929528, alfredod@vodafone.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (total amount) of errors in facial emotion recognition (time frame: an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465566, which also lists 2 linked publications.
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 2 Nov 2018.