[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05947045":3,"trial-entities:NCT05947045":116,"trial-summary:NCT05947045":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":55,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":81,"locations":84,"central_contacts":98,"overall_officials":101,"references":106,"see_also_links":107},"NCT05947045","COGVR","Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors","RECRUITING","2027-03","2026-06","2026-06-17","2023-06-22","St. Jude Children's Research Hospital","OTHER",true,"The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are:\n\n1. Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects?\n2. Will cognitive training via virtual reality provide neurocognitive benefits?\n3. Will there be predictable changes in brain activity as measured by neuroimaging?\n\nFindings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.","The objectives of this study are:\n\nPrimary Objective:\n\n• To estimate the participation rate, intervention adherence, and side effects of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors.\n\nSecondary Objectives:\n\n* To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad.\n* To evaluate patterns of cortical activation (oxygenated and deoxygenated hemoglobin responses) pre- and post- cognitive training in the virtual reality setting and on an iPad.\n\nThe investigators will use a randomized, single blind (psychology examiner), parallel group design (cognitive training via iPad versus virtual reality) to test hypotheses about behavioral and neurophysiological changes associated with cognitive training in childhood cancer survivors. The investigators will recruit patients who are being treated for a BT with radiotherapy. Patients will participate in study sessions in the Psychology Clinic during routine visits to St. Jude for radiotherapy. fNIRS studies will be conducted with participants randomized to both the virtual reality and iPad groups pre- and post- Cogmed training sessions. The time period between pre- and post-cognitive assessments will be 2 to 4 weeks for both virtual reality and iPad groups.\n\nParticipants will be enrolled until 30 patients initiating radiotherapy for a BT are evaluable, with approximately 20 randomized to the virtual reality group and 10 to the iPad group. The investigators expect to recruit and screen up to 45 patients to ascertain 30 eligible participants.\n\nEnrollment and assessment will be completed approximately 18 months after the study begins. Imaging data will be processed approximately two years after the study begins, and study findings will be disseminated within three years after the study begins.\n\nData management and statistical analysis will be provided locally by the Department of Psychology, the Neuroimaging Division of Radiological Sciences and the Biostatistics Department at St. Jude Children's Research Hospital",[18],"Brain Tumor",[20,21,22,23,24],"Radiotherapy","Brain tumor","Cognitive training","Virtual Reality","Working memory","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},45,"ESTIMATED",[33,38],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Cognitive training via iPad","Participants will complete five sessions of the Cogmed training program on an iPad. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training.",[37],"IPad Cogmed Training",{"type":13,"name":39,"description":40,"armGroupLabels":41},"Cognitive training via virtual reality","Participants will complete five sessions of the Cogmed training program within virtual reality. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training.",[42],"Virtual Reality Cogmed Training",[44,48,52],{"measure":45,"description":46,"timeFrame":47},"Participation Rate","The participation rate of this study (i.e., how many patients agree to participate\u002Fhow many patients are approached for participation) and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants.","After approach for enrollment, an average of 3 weeks after starting radiation therapy",{"measure":49,"description":50,"timeFrame":51},"Adherence","The completion of cognitive training sessions is defined as completion of four out of five planned sessions. The rate of completion of cognitive training sessions and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants, and separately for virtual reality and iPad administration groups.","At the completion of radiation therapy, an average of 6 weeks after enrollment",{"measure":53,"description":54,"timeFrame":51},"Side Effects","Summary statistics, including counts and percentages of side effects\u002Fcyber sickness symptoms will be provided at pre-, immediate-, and 1-hour post-cognitive training for participants completing training via the iPad or virtual reality.",[56,60],{"measure":57,"description":58,"timeFrame":59},"Neurobehavioral","To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad. The effect size of the change in cognitive outcomes is defined as the difference in group means\u002Fstandard deviation (e.g., Cohen's d). The effect size will be calculated separately for change in cognitive outcomes for cognitive training in the virtual reality setting or on iPad. The effect size of the difference of the change between two groups will also be estimated.","After completion of post-training assessment, an average of 8 weeks after enrollment",{"measure":61,"description":62,"timeFrame":59},"Cerebral Hemodynamics","To evaluate patterns of cortical activation (oxygenated hemoglobin response) pre- and post- cognitive training on the iPad and in the virtual reality setting. The effects of VR and iPad based cognitive training will be assessed by n-back and grid-based spatial working memory tasks in conjunction with fNIRS brain imaging of the prefrontal cortex.","ALL","8 Years","22 Years",false,{"inclusion":68,"exclusion":74,"raw_text":80},[69,70,71,72,73],"Initiating radiotherapy for a BT","Between 8-22 years of age at the time of enrollment","English or Spanish as the primary language","Research participant and one parent willing to participate and provide consent\u002Fassent according to institutional guidelines","Participant willing to take part in required aspects of Cogmed training",[75,76,77,78,79],"Significant impairment in global intellectual functioning (estimated or full scale IQ \\\u003C 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \\[NOPP\\])","History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness","Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures\u002Fphotosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)","Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)","Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation\u002Fplanning but not daily treatment)","Inclusion Criteria:\n\n* Initiating radiotherapy for a BT\n* Between 8-22 years of age at the time of enrollment\n* English or Spanish as the primary language\n* Research participant and one parent willing to participate and provide consent\u002Fassent according to institutional guidelines\n* Participant willing to take part in required aspects of Cogmed training\n\nExclusion Criteria:\n\n* Significant impairment in global intellectual functioning (estimated or full scale IQ \\\u003C 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \\[NOPP\\])\n* History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness\n* Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures\u002Fphotosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)\n* Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)\n* Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation\u002Fplanning but not daily treatment)",[82,83],"CHILD","ADULT",[85],{"facility":12,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":95},"Memphis","Tennessee","38105","United States",[91],{"role":92,"phone":93,"email":94},"CONTACT","888-226-4343","referralinfo@stjude.org",{"lat":96,"lon":97},35.14953,-90.04898,[99],{"name":100,"role":92,"phone":93,"email":94},"Heather Conklin, PhD",[102,105],{"name":103,"affiliation":12,"role":104},"Andrew Heitzer, PhD, ABPP-CN","PRINCIPAL_INVESTIGATOR",{"name":100,"affiliation":12,"role":104},[],[108,110,113],{"label":12,"url":109},"http:\u002F\u002Fwww.stjude.org",{"label":111,"url":112},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"label":114,"url":115},"St. Jude Brain Tumor Studies","http:\u002F\u002Fwww.stjude.org\u002Fresearch\u002Fclinical-trials.html#c671955e2f6ffa4a5f9cd8cf39931465e1f28ef99042...",{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Brain Neoplasm",[],{"nct_id":4,"found":14,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is a randomized study with about 45 participants. You would be assigned to either the iPad or virtual reality cognitive training group.","completed","Cognitive Training for Children with Brain Tumors Undergoing Radiotherapy","This study is looking at whether cognitive (brain) training using virtual reality is practical and well-received by children aged 8 to 22 who are receiving radiation therapy for brain tumors. Participants will be randomly assigned to either receive cognitive training through an iPad or through virtual reality. Both groups will complete five 15-20 minute training sessions over one to two weeks while on campus for radiotherapy. Researchers want to see how many people participate, how well they stick to the training, and if there are any side effects. They also want to compare how cognitive skills change and how brain activity is affected in both groups. The goal is to understand if virtual reality is a good way to deliver this type of training.","Researchers will check on your participation, adherence, and side effects at the completion of radiation therapy, which is about 6 weeks after you enroll.",124,"You would complete five 15-20 minute cognitive training sessions over one to two weeks, along with cognitive testing and brain scans (fNIRS) before and after the training.","Not stated in the trial record.",[],"v2"]