Clinical trial NCT02071186: The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With ADHD
Official title: The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that cognitive remediation and virtual reality treatment approaches can enhance cognitive and motor function in children with ADHD.

Detailed description: Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurobehavioral disorder affecting children. ADHD is currently treated with a combination of medication and behavioral therapy aimed at reducing the negative symptoms. Pharmacologic treatment methods, such as the use of Methylphenidate (MPH) have many drawbacks including high cost and side effects.

Non-pharmacological treatment approaches teach strategies aimed at improving behavior and environmental management. Evidence on efficacy of these treatments is lacking and the literature only supports the 'parental education' approach.

Motor aspects of the disorder tend to be undertreated. Studies have shown that persistent use of MPH has a positive effect on motor output timing and coordination in children with ADHD. Thus non-pharmacological interventions aimed at improving attention are likely to also improve other aspects of the disorder such as motor problems and thus should be further explored.

Various computerized remediation programs have been developed as a non-pharmacological alternative for children with ADHD. The programs present exercises that require sustained attention and a response to set rules and are often graded in task complexity according to the user's abilities.

Virtual Reality (VR) is a simulation of the real world using computer graphics that requires interaction, immersion and active participation by the user. VR applications have shown to be effective in improving attention in children and adolescents with behavioral problems, teaching them to focus on some tasks more than existing cognitive training programs. VR while walking has demonstrated improvements in both motor and cognitive function in older adults and patients with neurodegenerative diseases suggesting a beneficial effect on motor and cognitive function. However this treatment has not been tested yet in ADHD.

The study will investigate the following aims:

1. To compare the effect of computerized cognitive remediation and VR on attention and gait in children with ADHD.
2. To examine the long term effects of computerized cognitive remediation and VR on attention and gait in children with ADHD.
3. To compare, in an exploratory analysis, the effects of the non-pharmacological training paradigms to standard of care treatment on attention and gait in children with ADHD.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with ADHD by a pediatrician, child neurologist or child psychiatrist, according to the ADHD criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition.
* Attending regular education frameworks
* Have access to a personal computer at home

Exclusion Criteria:

* Children on active medication for ADHD during the study period
* Are taking any other medication that could affect attention, balance or motor function
* Have a serious medical condition that could affect attention, gait or balance
* Have any known genetic syndromes, autism, neurological conditions or psychiatric disorders or any medical illness requiring immediate treatment
* Are participating in a competing exercise program designed to improve gait or balance

Primary outcomes:
measure: Immediate change in gait function
timeFrame: One week post intervention
measure: Immediate change in cognitive function
timeFrame: One week post intervention
Secondary outcomes:
measure: Retention of change in gait function
timeFrame: One month post intervention
measure: Retention of change in cognitive function
timeFrame: One month post intervention
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Yael Leitner, MD
role: PRINCIPAL_INVESTIGATOR
References: