Pediatric Onset Multiple SclerosisNCT03190902
Cognitive Impairment in Pediatric Onset Multiple Sclerosis
A study testing Attention Processing Training program (APT) and nonspecific computer training (n-ST) in people with Pediatric Onset Multiple Sclerosis and ADHD Predominantly Inattentive Type, run by Pietro Iaffaldano.
Trial summary
Computer-assisted rehabilitation of attention deficits in pediatric Multiple Sclerosis and ADHD patients recruited during the study "Cognitive impairment in Pediatric Onset Multiple Sclerosis: research of biomarkers predictive of cognitive impairment progression". Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Onset Multiple Sclerosis, ADHD Predominantly Inattentive Type
- What is being tested?
- Attention Processing Training program (APT) and nonspecific computer training (n-ST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2015to 30 Apr 2016
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- POMS diagnosed according to the most recent diagnostic criteria;
- age <18 years;
- Expanded Disability Status Scale (EDSS) score ≤5.5;
- impairment on at least 2/4 attention tests defined as scores <1.5 standard deviation (SD) of normative values;
- ADHD patients with the subtype inattention;
- ADHD diagnosis performed according the DSM-5 criteria and the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention- Deficit/Hyperactivity Disorder (MTA) - Swanson, Nolan, and Pelham IV Rating Scale (MTA-SNAP-IV), Conner's Parent Rating Scale Revised (CPRS-R), Conner's Teacher Rating Scale Revised (CTRS-R), Child Behavior Checklist (CBCL), Kiddie Schedule for Affective Disorder and Schizophrenia (K-SADS);
- age <18 years;
- impairment on at least 2/4 attention tests defined as scores <1.5 standard deviation (SD) of normative values;
Who cannot join
- severe cognitive impairment (performance ≤2.0 SD of normative values);
- severe visual loss (unable to read Times New Roman font 16 with the best correction);
- major psychiatric illness;
- alcohol or substance abuse;
- education <5 years;
- previous cognitive rehabilitation training;
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- ongoing relapse or steroid treatment during the 30 days preceding enrollment;
- ADHD subtype hyperactivity;
- previously exposure or treatment with any psychotropic drug.
About this study
Official title: Cognitive Impairment in Pediatric Onset Multiple Sclerosis: Research of Biomarkers Predictive of Cognitive Impairment Progression
Computer-assisted rehabilitation of attention deficits in pediatric Multiple Sclerosis and ADHD patients recruited during the study "Cognitive impairment in Pediatric Onset Multiple Sclerosis: research of biomarkers predictive of cognitive impairment progression".
Read the detailed description
The presence of cognitive deficits of varied intensity is characteristic of psychiatric disorders of childhood and adolescence such as Attention Deficit Hyperactivity Disorder (ADHD), but also of neurological pathologies such as pediatric onset multiple sclerosis (POMS).
ADHD is one of the most common neurodevelopmental disorders characterized by pervasive patterns of inattention and/or impulsivity/hyperactivity and a range of cognitive dysfunctions that often persist into adulthood.
POMS represent 5-10% of total MS population. Cognitive dysfunction is one of the most remarkable features of MS, and, particularly in POMS, the percentage of patients with at least a mild cognitive deficit ranges from 30 to 80%. The most affected cognitive domains in POMS are complex attention, information processing speed, executive functions, verbal and visual memory, reasoning and problem solving.
The functional consequences of cognitive impairment can be particularly striking in children and adolescents since they occur during formative years in the academic career and may affect their social activities. Cognitive training, during the developmental age, when brain plasticity is at the highest expression, can induce a strengthening of the key brain networks implicated in POMS and ADHD. To date the efficacy of specific cognitive rehabilitation interventions has never been evaluated by a randomized controlled trials (RCTS) in POMS. Conversely, in the last years, several RCTs assessed the efficacy of cognitive training as a potential non-drug alternative treatment for ADHD disorder.Most of the cognitive trainings focused on the working memory or attention dysfunctions. Preliminary evidence suggests that cognitive remediation might be at least partially effective in the ADHD treatment. It is argued that cognitive training can reduce ADHD symptoms and improve functioning by targeting neuropsychological deficits thought to mediate ADHD pathophysiology.
During the study project "Cognitive impairment in Pediatric Onset Multiple Sclerosis: research of biomarkers predictive of cognitive impairment progression", which is aimed to assess clinical, radiological and biological markers in pediatric subjects, POMS and ADHD patients will be recruited to assess the efficacy of a home-based computerized program for retraining attention dysfunction.
- Being tested
- Attention Processing Training program (APT), nonspecific computer training (n-ST)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Processing Training program (APT)Behavioural
nonspecific computer training (n-ST)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| specific computer training (ST) - POMS | Experimental | Not described Receives: Behavioral: Attention Processing Training program (APT) |
| nonspecific computer training (n-ST) - POMS | Active comparator | Not described Receives: Behavioral: nonspecific computer training (n-ST) |
| specific computer training (ST) - ADHD | Experimental | Not described Receives: Behavioral: Attention Processing Training program (APT) |
| nonspecific computer training (n-ST) - ADHD | Active comparator | Not described Receives: Behavioral: nonspecific computer training (n-ST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effect of the cognitive training on neuropsychological performances.
A global score, defined Cognitive Impairment Index (CII), allowing the evaluation of changes in cognitive performances independently by the number of cognitive tests failed at the neuropsychological evaluation, will be obtained using the mean and SD from the normative values for each test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start15 Sep 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Onset Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, double blind, randomized clinical trial (RCT).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pietro Iaffaldano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pietro Iaffaldano, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190902
- Sponsor's protocol ID
- CR001
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simone M, Viterbo RG, Margari L, Iaffaldano P. Computer-assisted rehabilitation of attention in pediatric multiple sclerosis and ADHD patients: a pilot trial. BMC Neurol. 2018 Jun 8;18(1):82. doi: 10.1186/s12883-018-1087-3.
PubMed 29884144
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in Pediatric Onset Multiple Sclerosis: Research of Biomarkers Predictive of Cognitive Impairment Progression
- ClinicalTrials.gov ID
- NCT03190902
- Acronym / sponsor ID
- CR001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pietro IaffaldanoUniversity, hospital or other
- Study start
- 15 Sep 2015
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 19 Jun 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.
Computer-assisted rehabilitation of attention deficits in pediatric Multiple Sclerosis and ADHD patients recruited during the study "Cognitive impairment in Pediatric Onset Multiple Sclerosis: research of biomarkers predictive of cognitive impairment progression".
Detailed description
The presence of cognitive deficits of varied intensity is characteristic of psychiatric disorders of childhood and adolescence such as Attention Deficit Hyperactivity Disorder (ADHD), but also of neurological pathologies such as pediatric onset multiple sclerosis (POMS).
ADHD is one of the most common neurodevelopmental disorders characterized by pervasive patterns of inattention and/or impulsivity/hyperactivity and a range of cognitive dysfunctions that often persist into adulthood.
POMS represent 5-10% of total MS population. Cognitive dysfunction is one of the most remarkable features of MS, and, particularly in POMS, the percentage of patients with at least a mild cognitive deficit ranges from 30 to 80%. The most affected cognitive domains in POMS are complex attention, information processing speed, executive functions, verbal and visual memory, reasoning and problem solving.
The functional consequences of cognitive impairment can be particularly striking in children and adolescents since they occur during formative years in the academic career and may affect their social activities. Cognitive training, during the developmental age, when brain plasticity is at the highest expression, can induce a strengthening of the key brain networks implicated in POMS and ADHD. To date the efficacy of specific cognitive rehabilitation interventions has never been evaluated by a randomized controlled trials (RCTS) in POMS. Conversely, in the last years, several RCTs assessed the efficacy of cognitive training as a potential non-drug alternative treatment for ADHD disorder.Most of the cognitive trainings focused on the working memory or attention dysfunctions. Preliminary evidence suggests that cognitive remediation might be at least partially effective in the ADHD treatment. It is argued that cognitive training can reduce ADHD symptoms and improve functioning by targeting neuropsychological deficits thought to mediate ADHD pathophysiology.
During the study project "Cognitive impairment in Pediatric Onset Multiple Sclerosis: research of biomarkers predictive of cognitive impairment progression", which is aimed to assess clinical, radiological and biological markers in pediatric subjects, POMS and ADHD patients will be recruited to assess the efficacy of a home-based computerized program for retraining attention dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Single center, double blind, randomized clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| specific computer training (ST) - POMS | Experimental | Behavioral: Attention Processing Training program (APT) |
| nonspecific computer training (n-ST) - POMS | Active comparator | Behavioral: nonspecific computer training (n-ST) |
| specific computer training (ST) - ADHD | Experimental | Behavioral: Attention Processing Training program (APT) |
| nonspecific computer training (n-ST) - ADHD | Active comparator | Behavioral: nonspecific computer training (n-ST) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- POMS diagnosed according to the most recent diagnostic criteria;
- age <18 years;
- Expanded Disability Status Scale (EDSS) score ≤5.5;
- impairment on at least 2/4 attention tests defined as scores <1.5 standard deviation (SD) of normative values;
- ADHD patients with the subtype inattention;
Key exclusion criteria (9 listed)
- severe cognitive impairment (performance ≤2.0 SD of normative values);
- severe visual loss (unable to read Times New Roman font 16 with the best correction);
- major psychiatric illness;
- alcohol or substance abuse;
- education <5 years;
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 |
|---|---|---|
| Attention Processing Training program (APT) | Behavioural | specific computer training (ST) - ADHD, specific computer training (ST) - POMS |
| nonspecific computer training (n-ST) | Behavioural | nonspecific computer training (n-ST) - ADHD, nonspecific computer training (n-ST) - POMS |
Primary outcome
to evaluate the effect of the cognitive training on neuropsychological performances.
Time frame: 3 months
A global score, defined Cognitive Impairment Index (CII), allowing the evaluation of changes in cognitive performances independently by the number of cognitive tests failed at the neuropsychological evaluation, will be obtained using the mean and SD from the normative values for each test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Derived from this study: PubMed 29884144Simone M, Viterbo RG, Margari L, Iaffaldano P. Computer-assisted rehabilitation of attention in pediatric multiple sclerosis and ADHD patients: a pilot trial. BMC Neurol. 2018 Jun 8;18(1):82. doi: 10.1186/s12883-018-1087-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Processing Training program (APT) and nonspecific computer training (n-ST) in people with Pediatric Onset Multiple Sclerosis and ADHD Predominantly Inattentive Type, run by Pietro Iaffaldano.
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 9 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: finished, as of the sponsor's last update on 19 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the effect of the cognitive training on neuropsychological performances. (time frame: 3 months). 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 NCT03190902, which also lists 1 linked publication.
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 19 Jun 2017.