Cognitive Impairment in Pediatric Onset Multiple Sclerosis

NCT03190902 | Completed

• 1 other identifier: CR001
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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".

Conditions

Pediatric Onset Multiple Sclerosis; ADHD Predominantly Inattentive Type

Outcome Measures

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.

  3 months

Study Arms (4)

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)

Interventions

Attention Processing Training program (APT) BEHAVIORAL

specific computer training (ST) - ADHD; specific computer training (ST) - POMS

nonspecific computer training (n-ST) BEHAVIORAL

nonspecific computer training (n-ST) - ADHD; nonspecific computer training (n-ST) - POMS

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pietro Iaffaldano: lead

Related Publications (1)

• 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.

  PMID: 29884144 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Single center, double blind, randomized clinical trial (RCT).

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: September 15, 2015
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share