Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Cognitive Dysfunction

Motor Skills Disorders

Infratentorial Neoplasms

Mental Disorders

Psychotic Disorders

Neurodevelopmental Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Training Group recieved cognitive and Motor training included 6 sessions using the following training devices.

* Dynavision D2 ® (USA) (https://products.dynavisioninternational.com/products/d2) presents a panel with 64 bulbs which take the form of five circles. The task of a participant is to press the bulb that is glowing as quick as possible. In the trial 8 modes will be used; they have different instructions which are aimed at visual-motor co-ordination, processing speed, inhibition, and shifting.
* Fitlight Trainer ® (Canada) (https://www.fitlighttraining.com) consists of 7 clickers, and the tasks are similar to Dynavision ones.
* NeuroTracker ® (Canada) (https://neurotracker.net) includes a task of multiple object training for working memory and attention enhancement.

Control Group didn't recieved any cognitive and motor training. They visited swimming pool and physical therapy.

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.

Cognitive and Motor Training

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.

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.

Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors

The Effect of Cognitive and Motor Training on Executive Functions, Motor Skills, and Saccadic Eye Movements System in Pediatric Posterior Fossa Tumor Survivors

The software product, within which the interaction between patients and specialists will be realized, is supposed to be created in the Splunk system. The system allows to search both the real-time data and the archived data, based on the results of the search Splunk gives you the opportunity to: analyze the results with the visualization tools, generate reports and warnings, create a monitoring and notification systems in real time. These can be expanded - you can create new applications using the specialized development platform that comes with Splunk. The study will be attended by at least 1000 patients and their families who have concluded an agreement with the Medical-Rehabilitation Scientific Center "Russe pole", and come to the examination at least 2 times a year.

Following outcomes are mesuared: Execution time, Number of Fixations, Scan Path, Mean Duration of Fixations, Mean Saccades Amplitude, Ellipse Square

Following outcomes are mesuared: Visual-motor integration, Visual perception, Motor coordination.

Following outcome are mesuared: Reaction Time

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)

Following outcomes are mesuared: Fine Motor Skills, Gross Motor Skills, Coordination, Strength and Agility, General Score

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Skin and Connective Tissue Diseases

Substance Related Disorders

Breast Neoplasms

Chemotherapy-Related Cognitive Impairment

Cognition Disorders

Neurocognitive Disorders

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals being measured and logged. Data will be uploaded on a secure cloud server to which clinicians will have access.

Participants will perform web-based game play while wearing sham equipment. Duration of sessions will be fixed and frequency of sessions will equal that of the experimental group training. Over the total training the control group will have an equal duration of training with the experimental group.

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals and subjective pain level being measured and logged.

They will wear a computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants will play an increasing number of games, targeted at cognitive domains of executive function (primary), memory and attention. At the end of every session vitals and subjective pain will be measured and logged.

Clinical Coordinator will call homes weekly to ascertain general health and issues with participation.

At the end of week 4 and 8 participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire to gauge perceived benefits and technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale.

Telerehabilitation Experimental Group

Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty.

Sham group controls will start every session with vitals and subjective pain levels being measured and logged. Then participants will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to a server maintained by the company doing the web games. Data will then be transferred to the research team.

At the end of every session vitals and subjective pain levels will again be measured and logged.

Once a week the Clinical Coordinator will call the home to ascertain general health and determine is there were issues with that week participation.

Telerehabilitation Sham Control Group

Grigore C Burdea, PhD

Edward A Burde, MS

Jasdeep Hundal, PsyD

Daniel Valdivia, M.S.

Edward A Berde, MS

Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations on a wearable device enhanced with biosensors.

Participants are stage II and stage III breast cancer survivors with lasting cognitive impairments following their first round of chemotherapy. They will be randomized 1:1 into an experimental group and a sham control group. Each group will train in the home for 8 weeks, during which they will perform up to 4 rehabilitation sessions/week (based on tolerance). Each session will start with vitals being measured and logged. Each group will have three clinical evaluations: 1) at baseline; 2) at 8 weeks post-baseline; and 3) at 16 weeks from baseline for follow up.

Experimental group sessions will consist of increasingly more difficult cognitive training tasks in the form of simulated tasks. Biosensors will be sampled while participants interact with these games while wearing the computer system.

Sham control group will have the same number, suration and frequency of sessions, however they will play web games while wearing some the same biosensors.

Caregivers of all subjects will receive a laptop to be used in filling subjective evaluation forms and sending messages to research team. Training will be in the home, so caregivers will need to support the trials by ensuring compliance with the protocol.

All subjects will undergo standardized clinical evaluations at baseline, at 8 weeks and at 16 weeks from baseline. The subjects in the experimental group will have computerized measures taken during each session, and will fill subjective evaluation forms every 4 weeks of active training.

This portion of the study is intended to provide information pertaining to the feasibility of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting cognitive impairments subsequent to their first chemotherapy regimen, and living in the community with a caregiver.

We aim primarily at determining any clinical benefits in improved cognition (primarily in the executive functions domain), but also increased independence in ADLs, and improved mood (reduced depression). Another outcome is the degree of technology acceptance by the targeted population. Training will be done in the home, thus co-dwelling caregivers will also be recruited.

Specific aims are:

1. testing of a wearable device modified with added biosensors, by breast cancer survivors with CRCI.
2. new technology acceptance and ease of use at home by these individuals;
3. clinical benefit to improved cognition (primarily executive functions and cognitive endurance) when experimental therapy is added to daily routine vs. daily routine plus web-based cognitive games;
4. a therapist console module and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review.

Participants will be randomized equally in an experimental group, or a sham control group. Experimental subjects will receive computer-based therapy, of increasing duration and intensity for up to 4 sessions/week for 8 weeks. The length of sessions will increase from 15 minutes in week 1 to 40 minutes of actual play in week 8. The longer sessions will also train cognitive endurance, or the ability for sustained cognitive effort. All experimental subjects will have their exercise duration and intensity data logged into the database and investigators will monitor them remotely. An Artificial Intelligence (AI) software layer in the system will progress game difficulty based on success in the games as well as on degree of cognitive engagement, as estimated by the biosensors. Higher cognitive difficulty will be indicative of improved cognition, thus progress in mitigating cognitive impairments subsequent to chemotherapy. Additionally, the duration of training will also be logged, as will be the frequency of training. Longer sessions will be indicative of ability to sustain cognitive engagement longer. Additional input will be obtained from caregivers in the form of periodic questionnaires.

Fatigue will be self-reported during weekly follow up calls by a Clinical Coordinator. Participants will train while seated, and (if needed) their arms can be supported on a table. Rest periods may be introduced as needed, to further mitigate fatigue.

At the end of every other week participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire aimed at gauging perceived benefits and possible technical difficulties when using the BrightGo system. Questions will be scored on a 5-point Likert scale.

Control group will perform an equal amount of web-based game play of assigned cognitive-oriented games.

All participants will undergo screening for cognitive impairments (to confirm Mild Cognitive Impairment at baseline). Then they will continue with their daily routine during their 8-week training, and will undergo a second clinical evaluation at the end of these 8 weeks. All participants will then undergo a third (follow up) evaluation at 8 weeks post-end of training.

Caregivers will support the training by helping ensure compliance to protocol, and will complete subjective evaluation forms to rate the perceive benefit of training for the person they care for.

All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues.

Feasibility Sham comparison study:

Participants are randomized equally into the experimental group and a sham control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.

Outcomes Assessor will not be told which group the participant is part of, so not be biased in evaluations.

Only female will be recruited, as this study targets breast cancer survivors.

Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments - Feasibility Study

Data will be anonymized and made available through scientific publications.

Form used at screening post-consent to determine a participant's propensity for simulation sickness \[Freiwald et al., 2020\]. The questionnaire asks participants 26 questions The first 13 questions ascertain the general heath and fitness of the subject, and have Yes/No answers The remaining 13 questions are score on a on a 5 point Likert scale, with five point Likert scales, referring to the frequency of each complaint's occurrence. These scales range from 0 to 4 with the labels "very rarely", "rarely", "occasionally", "frequently" and "very often".

Heart rate (Pulse) measured with a medical meter at start and end of each training session

Blood pressure (systolic and diastolic) measured with a medical meter at start and end of each training session

Measure of change in cognitive impairment for cancer survivors and their caregivers

Measure cognitive ability \[Pearson Education 2017\]

Measure of sustained attention \[Hartman 2006\]

Measure of word generation \[White and Stern 2003\]

A measure of executive functioning \[Raitan 1958\]

Verbal/auditory memory test \[Brandt 1991\];

Visual memory test \[Benedict et al., 1996\];

Quality of Life for Cancer Patients \[Ferrell, et al 2012\]. Form includes 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.

Each question is scored on a 0 to 10 scale.

Questionnaire for caregiver oncology quality of life \[Weitzner et al 1999\]

Measure of depression severity \[Beck 1996\]

measure of upper extremity range of motion

Objective measure of participant performance in the therapeutic games.

subjective evaluation on a Likert scale of system and perceived benefits by participant and by caregiver

measure of skin conductance (indicative of sweat) as an indirect indication of cognitive engagement, blinking rate and gaze.

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Bright Cloud International Corp

healthy early bilinguals functional magnetic resonance imaging

healthy late bilinguals functional magnetic resonance imaging

bilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging

Stimuli will be presented in 3 language conditions, French, English and "switch" in which the participant alternates between English and French every trial. A block design will be used, with 7 line drawings per language condition. Four 9-minute runs will be performed, there being 2 action runs and 2 object runs. In each run, there are 6 blocks of each language condition, presented in a fixed random order. No drawings are repeated. Each stimulus is preceded either by an English or a French prompt word ("to" or "faire" for actions and, "say" or "dire" for objects) for 450 msec; stimuli are presented for 1.5 seconds and followed by a blank screen for 1 second. Language blocks are separated by a variable duration (from 8 to 10 seconds).

functional magnetic resonance imaging

Vincent LUBRANO, MD, PhD

For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas.

The present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma.

Functional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either English or French) or in switch condition (English and French). A stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.

Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.

Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)

The primary judgment criteria is brain activity as measured by functional magnetic resonance imaging :

* In blocked vs. switched naming in control subjects
* In switched naming in early vs. late bilingual subjects
* In blocked vs. switched naming in early vs. late bilingual subjects

The secondary judgment criteria is brain activity measured by functional magnetic resonance imaging :

* In blocked vs. switched naming in the patients
* In French vs. English and English vs. French naming in the late bilinguals
* In French vs. English and English vs. French naming in the early bilinguals
* In French vs. LX and LX vs. French naming in the patients.

University Hospital, Toulouse

Quality of Life

Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests.

Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)

measures of executive functioning with tasks

Executive functions

measures of socio-cognitive functioning with tasks

social cognition

measures of quality of life with questionnaires

quality of life

Jeremy Besnard, PhD

Didier Le Gall

Significant advances in primary malignant brain tumors (PBT) treatment have led to dramatically improved survival, both in children and adults. However, survival has not come without a cost and aggressive treatment methods associated with significant long-term adverse effects, often referred to as "late effects" (Panigrahy \& Blüml, 2009). These effects are the medical, physical, cognitive and psychosocial sequelae associated with cancer and its treatments that generally emerge two to five years after treatment ends (e.g., Landier \& Bhatia, 2008).

The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One especially important cognitive domain is executive functioning, which refers to essential factors such as problem-solving, goal-directed behavior and the ability to maintain stable interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive impairments on behavioral regulation and quality of life, few studies were conducted with survivors of PBT specifically for the assessment of executive functioning. Another fundamental neuro-cognitive domain is social cognition, which refers to the ability to understand the intentions and beliefs of others (Frith \& Singer, 2008). Social cognitive deficits are expected to impair autonomy and relationships, but scarce attention has been devoted to the study of social cognition in survivors of PBT and no study has attempted to compare socio-cognitive data and measures of health-related quality of life. It is noteworthy that executive function and socio-cognitive skills improve throughout childhood and adolescence, and improvements in these skills have frequently been attributed to maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a greater impact of the disease and its treatment on these functions in children/adolescents.

First, the investigators will calculate the prevalence of cognitive and socio-cognitive deficits, by comparing the performances of patients (children/adolescents and adults) to normative data available for each tasks and to performances of healthy controls matched on socio-demographic criteria.

Second, the investigators will compare the neuropsychological scores for cognitive and socio-cognitive tasks to health related quality of life (HRQOL) data (composite scores and by domains). Comparisons of neuropsychological and HRQOL scores will be performed between the two populations (children / adolescents and adults).

Third, the investigators will compare the data from the two age groups for the aforementioned variables (cognitive and behavioral executive assessments, cognitive and affective TOM). The proximity of the tasks should provide valid elements of comparison. The investigators will compare the questionnaires in auto-and hetero-evaluation for each HRQOL scales, and also for executive behavioral questionnaires.

Finally, to evaluate the investigators will compare the HRQOL patients/relatives' data to measure the potential impact of the disease on HRQOL of relatives of PBT survivors and the potential link between these data.

Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life

Assessment of Executive and Socio-cognitive Functions in Child and Adult Survivors of Primary Brain Tumor: Impact on Patients' and Relatives' Quality of Life.

Executive functions will be assessed using executive cognitive tasks (Stroop task for inhibition, Modified Card Sorting Task for mental flexibility, Digit spans for working memory) and questionnaires (BRIEF for childrens and BRIEF-A for adults) for executive behavioral measures.

Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. So, these multiple measurements will be aggregated to determine the number of patients with pathological performances for executive tasks (tasks and questionaires).

The first task involves a mental representation or belief about the state of the world (eg, Samson, 2012). The items offered in this kind of task are used to assess the ability to understand that the belief to infer in a type of scenario does not correspond to the reality.

The second task will be the Faux Pas task (Stone et al., 1998). This task is composed of written scenarios and the subject must detect if someone has done or said something he should not have said- the "faux pas". If the subject detects that there was a faux pas, additional questions are asked to detect whether he/she understands the cognitive side and the emotional side of the faux pas.

Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. These multiple measurements will be aggregated to determine the number of patients with pathological performances.

Health-related quality of life (HRQOL) will be assessed in adults with the French validated version of the 36-Item Short Form Survey (SF-36; Ware \& Sherbourne 1992) and a specific questionnaire for assessing quality of life of patients with brain tumors (QLQ-C30-BN20), commonly used in the international literature (eg, Chen et al, 2012;. Pulenzas et al, 2014).

Regarding the HRQOL assessment in children, the choice fell on the Peds-Ql. The PEDS QL measures HRQOL with three major composite assessments -psychosocial, physical, and total HRQOL.

Standardized norms in French are available for questionaires, which permit determining if the performances are pathological. These measurements will be aggregated to determine the number of patients with abnormal performances for these questionaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors	NCT03951246	Childhood Cance... Cognitive Impai... Motor Skills Di... Posterior Fossa...	Cognitive and M...	6 Years - 17 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study	NCT04972019	Cognitive Impai...	Telerehabilitat... Telerehabilitat...	20 Years - 65 Years	Bright Cloud International Corp
Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.	NCT02391493	Bilingualism	functional magn...	18 Years -	University Hospital, Toulouse
Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life	NCT02693405	Primary Brain T... Neurocognition Quality of Life	Executive funct... social cognitio... quality of life	8 Years - 59 Years	University Hospital, Angers
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors	NCT03951246	Childhood Cance... Cognitive Impai... Motor Skills Di... Posterior Fossa...	Cognitive and M...	6 Years - 17 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors	NCT03951246	Childhood Cance... Cognitive Impai... Motor Skills Di... Posterior Fossa...	Cognitive and M...	6 Years - 17 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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