Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951246
• Other study ID #: 8?/15-17
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: May 2019
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer
• Cognitive Dysfunction
• Cognitive Impairment
• Infratentorial Neoplasms
• Motor Skills Disorders
• Posterior Fossa Tumor

Intervention

Other:
• Cognitive and Motor Training
In the first phase of the trial, all participants (patients and healthy children) will complete cognitive and motor functions assessment. Then the sample of patients who have cognitive/motor impairment will be randomized to an either Intervention or Control group. In the second phase of the trial, survivors in the Intervention Group will receive 6 sessions of cognitive and motor training during two weeks, and survivors in Control Group will undergo ….. After this treatment phase, motor and cognitive functions assessment will be conducted in all patients once again. In the third phase, the Control Group will be provided the active intervention (i.e. 6 sessions of cognitive and motor training during two weeks), while the Intervention Group engages in passive reading. After this, motor and cognitive functions assessment will be carried out in all patients once again.

Locations

Country	Name	City	State
Russian Federation	Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye tracking	Following outcomes are mesuared: Execution time, Number of Fixations, Scan Path, Mean Duration of Fixations, Mean Saccades Amplitude, Ellipse Square	Change from Baseline Eye tracking mesuares up to 2 weeks and follow-up after 4 weeks from Baseline
Primary	VMI	Following outcomes are mesuared: Visual-motor integration, Visual perception, Motor coordination.	Change from Baseline VMI mesuares up to 2 weeks and follow-up after 4 weeks from Baseline
Primary	Dynavision	Following outcome are mesuared: Reaction Time	Change from Baseline Dynavision mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
Primary	Fitlight	Following outcome are mesuared: Reaction Time	Change from Baseline Fitlight mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
Primary	Neurotracker	Following outcome are mesuared: Score	Change from Baseline Neurotracker mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
Primary	CANTAB	Following outcomes are mesuared: Pattern Recognition Memory Immediate, Pattern Recognition Memory Delayed, Spatial Recognition Memory, Spatial Working Memory (Mistakes), Spatial Working Memory (Strategy), Spatial Span, Rapid Visual Processing (Mistakes), Rapid Visual Processing (Median Latency)	Change from Baseline CANTAB mesuare up to 2 weeks and follow-up after 4 weeks from Baseline
Primary	BOT-2	Following outcomes are mesuared: Fine Motor Skills, Gross Motor Skills, Coordination, Strength and Agility, General Score	Change from Baseline BOT-2 mesuare up to 2 weeks and follow-up after 4 weeks from Baseline