[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04349852":3,"trial-entities:NCT04349852":145,"trial-summary:NCT04349852":149},{"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":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":99,"sex":100,"minimum_age":101,"maximum_age":102,"healthy_volunteers":103,"eligibility_criteria":104,"std_ages":118,"locations":121,"central_contacts":138,"overall_officials":141,"references":143,"see_also_links":144},"NCT04349852","20-00130","Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.","RECRUITING","2027-12-01","2026-04","2026-05-01","2021-08-01","NYU Langone Health","OTHER",true,"This project will examine if computerized cognitive remediation will improve working memory and attention in 25 adults with a mild, moderate, or severe brain injury and compare their cognitive performance to the control group of 25 adults with a mild, moderate, or severe brain injury. The control group will train on computerized Brain Games. Participants in both groups will be assessed prior to training and immediately post-training and one month-post training.","The study design will be randomized assignment with a control group. Participants in both groups will undergo three cognitive assessments at baseline, at the end of 30 cognitive training modules, and 1-month post-completion of the first follow-up assessment.",[18],"Traumatic Brain Injury",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},150,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","BrainHQ Cognitive Training Modules","The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. The subtests exercises include 6 modules for the experimental group: 1) Sound Sweeps: which is identify whether sound pitches are going up or down; 2) Memory Grids: matching pairs of words; 3) Syllable Stack: recognition of sequences of confusable syllables; 4) Fine Tuning: recognition of the order of confusable syllables; 5) To-Do List Training: reconstruction of sequences of verbal instructions; 6) In The Know: identification of details in a verbally presented story. Since the intervention is presented both visually and verbally through the computer, participants will be asked to complete their training in a quiet space and time to complete these activities.",[33],"BrainHQ Cognitive Training Arm",{"type":29,"name":35,"description":36,"armGroupLabels":37},"BrainHQ People Skills Modules","The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. BrainHQ will provide 6 training modules for the control group: Crossword Puzzle - retrieve words according to the provided prompts. Lineup Four - Connect four colored discs so that they form a line in the horizontal, vertical or diagonal direction. Bricks Breaking Hex -Connect and remove bricks of the same color to clear the board. War Ship (Similar to Battleship)- place 5 vessels in the area at the left-hand side and sink enemy's hidden ships at the right-hand side by guessing enemy ship locations. Gem Swap - Form a line of 3 or more identical gems by swapping their positions. Sudoku - Fill each row, column, and 3x3 square with numbers 1 to 9 without repetition. Participants will spend 35 minutes at each training session. Participants will be asked to complete their training in a quiet space and time to complete these activities.",[38],"BrainHQ People Skills Arm",[40,44,47,50,54,57,60,63,66,69,72,75,78,81,84,87,90,93,96],{"measure":41,"description":42,"timeFrame":43},"Change in participants' logical memory after participating in BrainHQ training","This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Logical Memory subtest which is a measure of a person's ability to recall a story told to them.","baseline, 1 week post training, 4 weeks post training",{"measure":45,"description":46,"timeFrame":43},"Change in participants' verbal working memory after participating BrainHQ training","This will be measured by the Auditory Consonant Trigram (ACT), the ACT is a standard assessment measure used to evaluate working memory, attention, and cognitive interference.",{"measure":48,"description":49,"timeFrame":43},"Change in participants' working memory after participating in BrainHQ training","This will be measured by the Wechsler Memory Scale-IV (WMS-IV), Digit Span subtest which is a measure of working memory in which the person maintains their attention to the list of spoken numbers and ask to recall and state the list of numbers.",{"measure":51,"description":52,"timeFrame":53},"Participants' vocabulary after participating in BrainHQ training","This will be measured by the Wechsler Adult Intelligence Scale IV, Vocabulary subtest which measure the ability to define specific words.","baseline",{"measure":55,"description":56,"timeFrame":53},"Participants' ability to recall information","This will be measured by the Wechsler Adult Intelligence Scale IV, Information subtest which assesses the ability to recall general knowledge and acquired facts on different topics related to science, geography, and history.",{"measure":58,"description":59,"timeFrame":53},"Participants' abstract reasoning","Measured by Wechsler Adult Intelligence Scale IV, Matrix Reasoning subtest which is a measure of abstract reasoning of visually presented stimuli.",{"measure":61,"description":62,"timeFrame":43},"Change in participants' level of reading","This will be measured by Test of Premorbid Functioning which is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.",{"measure":64,"description":65,"timeFrame":43},"Changes in the participants' processing speed","This will be measured by Digit Symbol Modality Test which is a is a standard assessment measure used to measure processing speed, working memory, attention, and executive functioning. The standardized oral version will be administered.",{"measure":67,"description":68,"timeFrame":43},"Change in participants' verbal memory","Measured by California Verbal Learning Test - II (CVLT). This test is a measure of verbal memory. A list of words is read aloud to the participants five times. After each list of words, the participant recalls the words. The participants will also be asked to recall the words from the list 20 minutes later.",{"measure":70,"description":71,"timeFrame":43},"Change in participants ability to assess auditory information","This will be assessed with the Paced Auditory Serial Addition Test (PASAT) - 3 \\& 2 second versions which measures complex mental manipulation by adding the two most recent numbers that are presented auditorily. There are two sets of numbers that are presented at two different speeds. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.",{"measure":73,"description":74,"timeFrame":43},"Change in participants' verbal attention.","Will be assessed with the Woodcock-Johnson - Understanding Directions subtest which is a measure of verbal attention. Participant are provided oral directions to point to different parts of pictures.",{"measure":76,"description":77,"timeFrame":43},"Change in participants' attention and verbal memory","Actual Reality Performance test is a measure of attention and verbal memory, which requires the participants to follow directions and sequence steps of computerized task.",{"measure":79,"description":80,"timeFrame":43},"Changes to participants' ability to understand social cues","Awareness of Social Inference Test (TASIT)- Short version: is a standard measure to recognize emotions and a speaker's intentions presented in a vignette.",{"measure":82,"description":83,"timeFrame":43},"Change in participants' sense of depression","This will be self reported using the Beck's Depression Inventory - II. This is a standardized instrument for the assessment of depression with a self-report questionnaire.",{"measure":85,"description":86,"timeFrame":43},"Change in participants' sense of anxiety","Measured by self reports with the Beck's Anxiety Inventory which is a self-report instrument for the assessment of anxiety.",{"measure":88,"description":89,"timeFrame":43},"Changes to participants' mental status","Will be measured using the Lifetime Experience Questionnaire, \\\\ a questionnaire to determine current and past mental.",{"measure":91,"description":92,"timeFrame":43},"Changes in participants' daily living","The Functional Behavior Profile Questionnaire will be used to measure daily living status. This is a standardized questionnaire regarding activities of daily living, executive functioning, participation, problems solving and social relationships.",{"measure":94,"description":95,"timeFrame":43},"Changes in the pattern of participants social lifestyle","This may be assessed with the Participation Assessment with Recombined Tools-Objective Questionnaire: A standardized questionnaire about social participation.",{"measure":97,"description":98,"timeFrame":43},"Changes in the participants' overall status","Will be gauged by using the Promis Global Health Questionnaire. This is a standardized questionnaire that evaluates physical, mental and social health deficits common in people with brain injuries.",[],"ALL","18 Years",null,false,{"inclusion":105,"exclusion":111,"raw_text":117},[106,107,108,109,110],"Medically documented mild, moderate, or severe TBI;","All subjects will be older than 18 years of age;","Free from schizophrenia or bipolar disorder, due to the potential influence of such disorders on cognitive functioning;","Free of current alcohol or drug abuse;","At least 12 months post-injury.",[112,113,114,115,116],"Younger than 18 years old.","A brain injury that is not medically documented.","Being diagnosed with schizophrenia or bipolar disorder.","Current alcohol or drug use diagnosis","Less than 3 months post-injury","Inclusion Criteria:\n\n* Medically documented mild, moderate, or severe TBI;\n* All subjects will be older than 18 years of age;\n* Free from schizophrenia or bipolar disorder, due to the potential influence of such disorders on cognitive functioning;\n* Free of current alcohol or drug abuse;\n* At least 12 months post-injury.\n\nExclusion Criteria:\n\n* Younger than 18 years old.\n* A brain injury that is not medically documented.\n* Being diagnosed with schizophrenia or bipolar disorder.\n* Current alcohol or drug use diagnosis\n* Less than 3 months post-injury",[119,120],"ADULT","OLDER_ADULT",[122],{"facility":12,"status":7,"city":123,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":135},"New York","10016","United States",[127,132],{"name":128,"role":129,"phone":130,"email":131},"George Voelbel, PhD","CONTACT","212-998-5827","gv23@nyu.edu",{"name":133,"role":134},"George Voelbel, Phd","PRINCIPAL_INVESTIGATOR",{"lat":136,"lon":137},40.71427,-74.00597,[139],{"name":140,"role":129,"phone":130,"email":131},"Gerald Voelbel, PhD",[142],{"name":140,"affiliation":12,"role":134},[],[],{"nct_id":4,"conditions":146,"biomarkers":148},[147],"Traumatic Encephalopathy",[],{"nct_id":4,"found":14,"summary":150,"prompt_version":160},{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This study is designed as a randomized assignment with a control group, planning to enroll 150 participants.","completed","Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury","This study is looking at whether computerized training can help improve memory and attention in adults who have had a traumatic brain injury (TBI). You would be assigned to one of two groups. One group will use BrainHQ Cognitive Training Modules, which are designed to improve different thinking skills. The other group will use BrainHQ People Skills Modules, which include activities like crossword puzzles. Researchers will measure your memory and working memory (the ability to hold and use information temporarily) before, right after, and one month after the training. To join, you must be at least 18 years old, have a documented TBI (mild, moderate, or severe), and be at least 12 months past your injury. You also cannot have certain mental health conditions or current alcohol\u002Fdrug abuse. The study aims to enroll 150 participants, but its current recruitment status is unclear.","Your memory and working memory will be measured at baseline, 1 week post training, and 4 weeks post training.",142,"You would undergo three cognitive assessments: at the start, after completing 30 training modules, and one month after the first follow-up assessment.","Not stated in the trial record.",[30,35],"v2"]