Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03951246
Other study ID # 8?/15-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Terminated NCT04493957 - Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Completed NCT04713384 - Remote Bimanual Virtual Rehabilitation Post CVD N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Completed NCT03698695 - A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers Phase 1
Not yet recruiting NCT05552729 - Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors Phase 1/Phase 2
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT03187353 - IMProving Executive Function Study Phase 4
Completed NCT03301402 - Air Purifier to Improve Endothelial Function and Carotid Intima Thickness N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Recruiting NCT04907565 - Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
Recruiting NCT05030285 - Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment N/A