Clinical trial NCT03951246: Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors
Official title: The Effect of Cognitive and Motor Training on Executive Functions, Motor Skills, and Saccadic Eye Movements System in Pediatric Posterior Fossa Tumor Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Cognitive Impairment
Motor Skills Disorders
Posterior Fossa Tumor
Keywords: executive functions
motor skills
eye tracking
pediatric cancer
posterior fossa tumors
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to create a rehabilitation program for children who survived posterior fossa tumors using the latest technology. Supposed that training in Fitlight, Dynavision D2, NeuroTracker will improve executive functions, visual-motor integration, fine and gross motor functions.

Detailed description: The death rates from posterior fossa tumors (PFT) have declined significantly over the past decades. Children and adolescents who survived this kind of tumor without metastases demonstrate 5-year survival rates of 90%. Standard treatment for posterior fossa tumors includes surgical rejection, which can be combined with radiotherapy and chemotherapy. However, treatment factors can cause the impairment of motor and cognitive functions, which influence negatively speech, academic achievements, and quality of life. Such an outcome can be induced by tumor growth process as well. One of the most essential consequences of the disease is cognitive deficiency in the areas of attention, working memory, and executive functions.

The cerebellum pathology often causes deficits of motor skills. Considering that motor system has a hierarchal organization, PFT can cause the impairment of all the system, starting with gross motor skills and ending in the finest eye movements. The cerebellum has been shown to control voluntary eye movements, particularly such parameters as accuracy and velocity of saccades, fixation duration, etc.

Given the effect of probable deficits on a child's daily life, the issue of cognitive and motor remediation programs is in the spotlight today. There is some evidence that interventions targeting cognitive functions (e.g. working memory, short-term memory, attention, planning) and motor skills (gross and fine motor skills, muscle strength, agility) can be effective in these patients.

However, only few of remediation programs focus on visual-motor co-ordination and saccadic eye movements system, despite the fact that they provide the basis for higher-level functions, such as sustained attention, working memory, and planning.

The research conducted in Clinical Rehabilitation Research Center "Russkoe Pole" has revealed that treatment gains in the areas of motor skills, and specifically saccadic eye movements, are positively associated with the enhancement of attention and working memory. Given this, the investigators can suggest that this improvement is connected with the reduction of extra saccadic movements and consequently the decrease of irrelevant information to be processed. This mechanism can be generalized to the other executive functions, such as shifting, inhibition, and planning.

This trial will allow the investigators to determine potential feasibility of rehabilitation program targeting motor and cognitive functions, as well as the saccadic system, in pediatric posterior fossa tumor survivors.

Eligibility criteria: Inclusion Criteria:

* Survivor of posterior fossa tumor/healthy control
* Currently aged 6-17
* Staying in Clinical Rehabilitation Research Center for 32 days
* Research participant or legal guardian/representative to give written informed consent

Exclusion Criteria:

* Currently on stimulants or other medications intended to treat motor or cognitive impairment
* History of seizures
* Severe deficits in vision, motor skills, or cognitive functions
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Primary outcomes:
measure: Eye tracking
timeFrame: Change from Baseline Eye tracking mesuares up to 2 weeks and follow-up after 4 weeks from Baseline
measure: VMI
timeFrame: Change from Baseline VMI mesuares up to 2 weeks and follow-up after 4 weeks from Baseline
measure: Dynavision
timeFrame: Change from Baseline Dynavision mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
measure: Fitlight
timeFrame: Change from Baseline Fitlight mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
measure: Neurotracker
timeFrame: Change from Baseline Neurotracker mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
measure: CANTAB
timeFrame: Change from Baseline CANTAB mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
measure: BOT-2
timeFrame: Change from Baseline BOT-2 mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Study officials:
References: