Clinical Trials Directory

Trials / Completed

CompletedNCT03190902

Cognitive Impairment in Pediatric Onset Multiple Sclerosis

Cognitive Impairment in Pediatric Onset Multiple Sclerosis: Research of Biomarkers Predictive of Cognitive Impairment Progression

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Pietro Iaffaldano · Academic / Other
Sex
All
Age
17 Years
Healthy volunteers
Not accepted

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".

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAttention Processing Training program (APT)
BEHAVIORALnonspecific computer training (n-ST)

Timeline

Start date
2015-09-15
Primary completion
2016-04-30
Completion
2016-04-30
First posted
2017-06-19
Last updated
2017-06-19

Source: ClinicalTrials.gov record NCT03190902. Inclusion in this directory is not an endorsement.