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CompletedNCT03190902Updated Jun 19, 2017

Cognitive Impairment in Pediatric Onset Multiple Sclerosis

An interventional study of Attention Processing Training program (APT) and nonspecific computer training (n-ST) in Pediatric Onset Multiple Sclerosis and ADHD Predominantly Inattentive Type, sponsored by Pietro Iaffaldano. Completed. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2017-06-19.

Sponsored by Pietro Iaffaldano · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Pediatric Onset Multiple Sclerosis
  • ADHD Predominantly Inattentive Type
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

This is the only study on the registry with Pietro Iaffaldano as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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;
  • ongoing relapse or steroid treatment during the 30 days preceding enrollment;
  • ADHD subtype hyperactivity;
  • previously exposure or treatment with any psychotropic drug.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    specific computer training (ST) - POMS

    Behavioral: Attention Processing Training program (APT)

  • Active comparator
    nonspecific computer training (n-ST) - POMS

    Behavioral: nonspecific computer training (n-ST)

  • Experimental
    specific computer training (ST) - ADHD

    Behavioral: Attention Processing Training program (APT)

  • Active comparator
    nonspecific computer training (n-ST) - ADHD

    Behavioral: nonspecific computer training (n-ST)

Interventions

  • BehavioralAttention Processing Training program (APT)
  • Behavioralnonspecific computer training (n-ST)
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03190902
Lead sponsor
Pietro Iaffaldano
Responsible party
Pietro Iaffaldano (MD, University of Bari) — Sponsor-investigator
First posted
Jun 19, 2017
Start date
Sep 15, 2015
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016
Last update
Jun 19, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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