EpilepsyNCT04292093
Efficacy Study of a Neuropsychological Rehabilitation Intervention for Children With Non-symptomatic Epilepsy
A study testing Home rehabilitation training in people with Epilepsy, run by IRCCS Eugenio Medea.
Trial summary
Patients with non-symptomatic epilepsy, even in the presence of a normative cognitive functioning, present different levels of neuropsychological weaknesses, especially in executive functions and social competences. Such difficulties can significantly influence academic achievement and social inclusion. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Home rehabilitation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 28 Feb 2022
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of non-symptomatic epilepsy;
- Absence of intellectual disability (total IQ> 70);
- Absence of significant visual, auditory or motor impairments that may prevent the use of the computerized training;
- Basic ability to use PC.
Who cannot join
- Presence of psychiatric comorbidity and / or behavioral disturbances that may hamper the participation to training sessions;
- Diagnosis of photosensitive epilepsy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Studio di Efficacia di Percorsi di Riabilitazione Neuropsicologica Tramite Piattaforma Lumosity: Evidenze Comportamentali e Neurofisiologiche in Pazienti Con Epilessia Non Sintomatica in età Pediatrica
Patients with non-symptomatic epilepsy, even in the presence of a normative cognitive functioning, present different levels of neuropsychological weaknesses, especially in executive functions and social competences. Such difficulties can significantly influence academic achievement and social inclusion. To date, there is limited evidence on small samples that training focusing on executive functions, also through tele-rehabilitation methods, may be effective in limiting these difficulties. Therefore, the purpose of this research project is to evaluate the effectiveness of a training of the executive functions (administered via the Lumosity platform) in patients with non-symptomatic focal and generalized epilepsy. A cognitive and behavioral assessment will be performed before and after the treatment to evaluate its efficacy. Moreover, a predefined neurophysiological marker will be recorded before and after treatment to detect changes in cortical activity which may reflect expected treatment effects.
Read the detailed description
First, all eligible patients will be screened for inclusion and exclusion and will be assigned to the experimental group and the control group. The experimental group will participate in a remote rehabilitation program via Lumosity platform, providing video-games aimed at strengthening specific cognitive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. The control group will watch a series of animated / TV shows, again for 30 minutes a day, 5 days a week, for 8 weeks. Once a week the patient (or his family) will be contacted by the researcher to check the progress of the treatment. All patients will be evaluated within a week before the start of treatment and after the end of treatment with a standardized neuropsychological assessment battery (NEPSY-II) designed to evaluate the effects of the treatment. Patients (or their parents according to participants' age) will also compile a questionnaire to assess behavioral problems (CBCL); a questionnaire for the assessment of cognitive functions in an ecological context (BRIEF-2); a quality of life questionnaire (TACQOL) and ad-hoc treatment appreciation questionnaire. In addition to the cognitive-behavioral assessment, specific parameters of cortical activity will be recorded (via EEG), in order to evaluate any changes in predefined neurophysiological markers able to reflect the effects of the treatment. Evidence gathered from the literature reports that the relationship between theta and beta waves (the so-called theta/beta ratio) may be considered an index of a behavioral adaptation deficit in populations with poor executive control. Therefore, this index appears to be the ideal candidate to detect changes in cortical activity which may underlay behavioral effects of home rehabilitation treatment. Thus, resting-state cortical activity will be recorded before and after the treatment.
- Conditions
- Epilepsy
- Being tested
- Home rehabilitation training, Home control activity
- Keywords
- Epilepsy, Children, Rehabilitation, Executive Functions
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home rehabilitation trainingBehavioural
The rehabilitation training will be provided via Lumosity platform. Participants will be asked to play computer video-games aimed at strengthening specific sub-functions pertaining to the macro area of executive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. Specifically, 20 games out of a total of 64 available games provided by the platform have been selected. The selected games are aimed at training 4 cognitive skills: memory, attention, cognitive flexibility and problem solving. In particular, 5 different games were chosen for each cognitive ability.
Home control activityBehavioural
The control group will watch a series of animated / TV shows suitable for the sample age, again for 30 minutes a day, 5 days a week, for 8 weeks. The videos will be provided by the experimenter and participants will watch them on their personal computer. At the end of each videos, participants will answer a series of multiple-choice questions aimed at evaluating the attention deployed to the content of the videos.
| Study group | Role | What they receive |
|---|---|---|
| Home rehabilitation training | Experimental | Home rehabilitation training Receives: Behavioral: Home rehabilitation training |
| Home control activity | Active comparator | Home control activity Receives: Behavioral: Home control activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEPSY-II Neuropsychological Battery
Assessment of executive functions, language, memory and visuo-spatial skills
Subscales (all subscales range from 1 to 19 scalar scores):
- Design fluency, raw score 0/70
- Auditory attention, 0/30 and Response Set 0/36
- Inhibition (denomination 0/80 - 0/360') (inhibition 0/80 - 480') (switching 0/80 - 480') REVERSE (higher raw scores indicate worse perfomance)
- Animal sorting, 0/12
- Word generation, 0/75
- Memory for faces, 0/32
- Word list interference (repetition 0/20; recall 0/40)
- Imitating hand position, (0/24)
- Visuo-motor precision (0/307; 0/360') REVERSE (higher raw scores indicate worse perfomance)
- Manual motor sequences, 0/60
- Affect recognition, 0/35
- Design copying (general 0/21; motor 0/42; global 0/42; local 0/36; total specific 0/120)
- Picture puzzles, 0/20
- Geometric puzzles, 0/40
Measured: baseline
Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
Assessment of general intellectual ability. Indexes (higher T scores indicate better perfomance for all indexes)
- Verbal Comprehension Index (40/160)
- Fluid Reasoning Index (40/160)
- Working Memory Index (40/160)
- Processing Speed Index (40/160)
- Full Scale IQ (40/160)
Measured: baseline
NEPSY-II Neuropsychological Battery (change)
Assessment of executive functions, language, memory and visuo-spatial skills
Measured: within 1 week after intervention
NEPSY-II Neuropsychological Battery (change)
Assessment of executive functions, language, memory and visuo-spatial skills
Measured: 3 month after intervention
Secondary outcomes (15)
Child Behavior Checklist (CBCL) (parent compiled for 6-18 years old participants)
Questionnaire for the assessment of emotional and behavioural problems.
The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
Measured: baseline
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Questionnaire for the assessment of emotional and behavioural problems.
YSR 11-18 is direcly compiled by adolescents aged 11-18 years. It provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
Measured: baseline
The Children's Quality of Life (TACQOL)
Questionnaire for the assessment of health-related quality of life.
Scales (higher raw scores indicate higher quality of life)
- Body (physical functioning) 0/32
- Motor functioning 0/32
- Autonomy 0/32
- Social functioning 0/32
- Cognition 0/32
- Emotions (positive) 0/16
- Emotions (negative) 0/16
Measured: baseline
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent compiled for 5-10 years old participants; self-report version for 11-18 years old participants)
Questionnaire for the assessesment of executive function and self-regulation competence.
The BRIEF (parent version) questionnaire is aimed at assessing executive functioning at home and school and contains 63 items. Raw scores of the global scale range from 63 to 189; T scores (M = 50, SD = 10). The self-report version contains 55 items. Raw scores of the global scale range from 55 to 165; T scores (M = 50, SD = 10). Higher scores mean a worse outcome.
Subscale and Indexes
- Inhibit
- Shift
- Self-Monitor
- Emotional Control
- Initiate
- Working Memory
- Plan/Organize
- Behavioral regulation Index
- Emotion regulation Index
- Cognitive regulation Index
- Global Executive Index
Measured: baseline
Theta/beta ratio
Low theta/beta ratio is a cortical activity considered an index of poor attentional resources. Its recording will be conducted with a 32-channels EEG system at rest (4 minutes: 2 min eyes open and 2 min eyes closed).
Measured: baseline
Child Behavior Checklist CBCL (change)
Questionnaire for the assessment of emotional and behavioural problems
The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
Measured: within 1 week after intervention
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Questionnaire for the assessment of emotional and behavioural problems.
YSR 11-18 is direcly compiled by adolescents aged 11-18 years. It provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
Measured: within 1 week after intervention
The Children's Quality of Life TACQOL (change)
Questionnaire for the assessment of health-related quality of life. Scales (higher raw scores indicate higher quality of life)
- Body (physical functioning) 0/32
- Motor functioning 0/32
- Autonomy 0/32
- Social functioning 0/32
- Cognition 0/32
- Emotions (positive) 0/16
- Emotions (negative) 0/16
Measured: within 1 week after intervention
Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
Questionnaire for the assessesment of executive function and self-regulation competence.
The BRIEF (parent version) questionnaire is aimed at assessing executive functioning at home and school and contains 63 items. Raw scores of the global scale range from 63 to 189; T scores (M = 50, SD = 10). The self-report version contains 55 items. Raw scores of the global scale range from 55 to 165; T scores (M = 50, SD = 10). Higher scores mean a worse outcome.
Subscale and Indexes
- Inhibit
- Shift
- Self-Monitor
- Emotional Control
- Initiate
- Working Memory
- Plan/Organize
- Behavioral regulation Index
- Emotion regulation Index
- Cognitive regulation Index
- Global Executive Index
Measured: within 1 week after intervention
Theta/beta ratio (change)
Low theta/beta ratio is a cortical activity considered an index of poor attentional resources. Its recording will be conducted with a 32-channels EEG system at rest (4 minutes: 2 min eyes open and 2 min eyes closed).
Measured: within 1 week after intervention
Ad-hoc compliance to treatment questionnaire
A 5 items of a 5-point Likert questionnaire created ad-hoc for the assessment of the compliance to the treatment.
Higher scores indicare better compliance (except for item 4)
Measured: within 1 week after intervention
Child Behavior Checklist CBCL (change)
Questionnaire for the assessment of emotional and behavioural problems
The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
Measured: 3 months after intervention
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Questionnaire for the assessment of emotional and behavioural problems.
YSR 11-18 is direcly compiled by adolescents aged 11-18 years. It provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
Measured: 3 month after intervention
The Children's Quality of Life TACQOL (change)
Questionnaire for the assessment of health-related quality of life.
Scales (higher raw scores indicate higher quality of life)
- Body (physical functioning) 0/32
- Motor functioning 0/32
- Autonomy 0/32
- Social functioning 0/32
- Cognition 0/32
- Emotions (positive) 0/16
- Emotions (negative) 0/16
Measured: 3 months after intervention
Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
Questionnaire for the assessesment of executive function and self-regulation competence.
The BRIEF (parent version) questionnaire is aimed at assessing executive functioning at home and school and contains 63 items. Raw scores of the global scale range from 63 to 189; T scores (M = 50, SD = 10). The self-report version contains 55 items. Raw scores of the global scale range from 55 to 165; T scores (M = 50, SD = 10). Higher scores mean a worse outcome.
Subscale and Indexes
- Inhibit
- Shift
- Self-Monitor
- Emotional Control
- Initiate
- Working Memory
- Plan/Organize
- Behavioral regulation Index
- Emotion regulation Index
- Cognitive regulation Index
- Global Executive Index
Measured: 3 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (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 Eugenio MedeaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Bardoni, MD, PhD, Principal investigator, Scientific Institute, IRCCS E. Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292093
- Sponsor's protocol ID
- 769
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 26 Mar 2020
- 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 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio di Efficacia di Percorsi di Riabilitazione Neuropsicologica Tramite Piattaforma Lumosity: Evidenze Comportamentali e Neurofisiologiche in Pazienti Con Epilessia Non Sintomatica in età Pediatrica
- ClinicalTrials.gov ID
- NCT04292093
- Acronym / sponsor ID
- 769
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Children, Rehabilitation, Executive Functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 2 Mar 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.
Patients with non-symptomatic epilepsy, even in the presence of a normative cognitive functioning, present different levels of neuropsychological weaknesses, especially in executive functions and social competences. Such difficulties can significantly influence academic achievement and social inclusion. To date, there is limited evidence on small samples that training focusing on executive functions, also through tele-rehabilitation methods, may be effective in limiting these difficulties. Therefore, the purpose of this research project is to evaluate the effectiveness of a training of the executive functions (administered via the Lumosity platform) in patients with non-symptomatic focal and generalized epilepsy. A cognitive and behavioral assessment will be performed before and after the treatment to evaluate its efficacy. Moreover, a predefined neurophysiological marker will be recorded before and after treatment to detect changes in cortical activity which may reflect expected treatment effects.
Detailed description
First, all eligible patients will be screened for inclusion and exclusion and will be assigned to the experimental group and the control group. The experimental group will participate in a remote rehabilitation program via Lumosity platform, providing video-games aimed at strengthening specific cognitive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. The control group will watch a series of animated / TV shows, again for 30 minutes a day, 5 days a week, for 8 weeks. Once a week the patient (or his family) will be contacted by the researcher to check the progress of the treatment. All patients will be evaluated within a week before the start of treatment and after the end of treatment with a standardized neuropsychological assessment battery (NEPSY-II) designed to evaluate the effects of the treatment. Patients (or their parents according to participants' age) will also compile a questionnaire to assess behavioral problems (CBCL); a questionnaire for the assessment of cognitive functions in an ecological context (BRIEF-2); a quality of life questionnaire (TACQOL) and ad-hoc treatment appreciation questionnaire. In addition to the cognitive-behavioral assessment, specific parameters of cortical activity will be recorded (via EEG), in order to evaluate any changes in predefined neurophysiological markers able to reflect the effects of the treatment. Evidence gathered from the literature reports that the relationship between theta and beta waves (the so-called theta/beta ratio) may be considered an index of a behavioral adaptation deficit in populations with poor executive control. Therefore, this index appears to be the ideal candidate to detect changes in cortical activity which may underlay behavioral effects of home rehabilitation treatment. Thus, resting-state cortical activity will be recorded before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home rehabilitation training | Experimental | Behavioral: Home rehabilitation trainingHome rehabilitation training |
| Home control activity | Active comparator | Behavioral: Home control activityHome control activity |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of non-symptomatic epilepsy;
- Absence of intellectual disability (total IQ> 70);
- Absence of significant visual, auditory or motor impairments that may prevent the use of the computerized training;
- Basic ability to use PC.
Key exclusion criteria (2 listed)
- Presence of psychiatric comorbidity and / or behavioral disturbances that may hamper the participation to training sessions;
- Diagnosis of photosensitive epilepsy.
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 |
|---|---|---|
| Home rehabilitation trainingThe rehabilitation training will be provided via Lumosity platform. Participants will be asked to play computer video-games aimed at strengthening specific sub-functions pertaining to the macro area of executive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. Specifically, 20 games out of a total of 64 available games provided by the platform have been selected. The selected games are aimed at training 4 cognitive skills: memory, attention, cognitive flexibility and problem solving. In particular, 5 different games were chosen for each cognitive ability. | Behavioural | Home rehabilitation training |
| Home control activityThe control group will watch a series of animated / TV shows suitable for the sample age, again for 30 minutes a day, 5 days a week, for 8 weeks. The videos will be provided by the experimenter and participants will watch them on their personal computer. At the end of each videos, participants will answer a series of multiple-choice questions aimed at evaluating the attention deployed to the content of the videos. | Behavioural | Home control activity |
Primary outcome
NEPSY-II Neuropsychological Battery
Time frame: baseline
Assessment of executive functions, language, memory and visuo-spatial skills Subscales (all subscales range from 1 to 19 scalar scores): * Design fluency, raw score 0/70 * Auditory attention, 0/30 and Response Set 0/36 * Inhibition (denomination 0/80 - 0/360') (inhibition 0/80 - 480') (switching 0/80 - 480') REVERSE (higher raw scores indicate worse perfomance) * Animal sorting, 0/12 * Word generation, 0/75 * Memory for faces, 0/32 * Word list interference (repetition 0/20; recall 0/40) * Imitating hand position, (0/24) * Visuo-motor precision (0/307; 0/360') REVERSE (higher raw scores indicate worse perfomance) * Manual motor sequences, 0/60 * Affect recognition, 0/35 * Design copying (general 0/21; motor 0/42; global 0/42; local 0/36; total specific 0/120) * Picture puzzles, 0/20 * Geometric puzzles, 0/40
Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
Time frame: baseline
Assessment of general intellectual ability. Indexes (higher T scores indicate better perfomance for all indexes) * Verbal Comprehension Index (40/160) * Fluid Reasoning Index (40/160) * Working Memory Index (40/160) * Processing Speed Index (40/160) * Full Scale IQ (40/160)
NEPSY-II Neuropsychological Battery (change)
Time frame: within 1 week after intervention
Assessment of executive functions, language, memory and visuo-spatial skills
NEPSY-II Neuropsychological Battery (change)
Time frame: 3 month after intervention
Assessment of executive functions, language, memory and visuo-spatial skills
15 secondary outcomes
Child Behavior Checklist (CBCL) (parent compiled for 6-18 years old participants)
Time frame: baseline
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Time frame: baseline
The Children's Quality of Life (TACQOL)
Time frame: baseline
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent compiled for 5-10 years old participants; self-report version for 11-18 years old participants)
Time frame: baseline
Theta/beta ratio
Time frame: baseline
Child Behavior Checklist CBCL (change)
Time frame: within 1 week after intervention
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Time frame: within 1 week after intervention
The Children's Quality of Life TACQOL (change)
Time frame: within 1 week after intervention
Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
Time frame: within 1 week after intervention
Theta/beta ratio (change)
Time frame: within 1 week after intervention
Ad-hoc compliance to treatment questionnaire
Time frame: within 1 week after intervention
Child Behavior Checklist CBCL (change)
Time frame: 3 months after intervention
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Time frame: 3 month after intervention
The Children's Quality of Life TACQOL (change)
Time frame: 3 months after intervention
Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
Time frame: 3 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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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.
Alessandra Bardoni, MD, PhD principal investigator
Scientific Institute, IRCCS E. Medea
Questions about this trial
What is this clinical trial studying?
A study testing Home rehabilitation training in people with Epilepsy, run by IRCCS Eugenio Medea.
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 2 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Alessandra Bardoni, MD, PhD (+39 031877111, alessandra.bardoni@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEPSY-II Neuropsychological Battery (time frame: baseline). 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?
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 26 Mar 2020.