Cognitive Training for Traumatic Brain Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NYU Langone Health
No Placebo Group
Trial Summary
What is the purpose of this trial?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 tasks of social awareness. Participants in both groups will be assessed prior to training and immediately post-training and one month-post training.
How is the BrainHQ Cognitive Training Modules treatment different from other treatments for traumatic brain injury?
The BrainHQ Cognitive Training Modules are unique because they focus on improving attention, memory, and social skills through interactive exercises, which can be more engaging and accessible compared to traditional therapies. Unlike some treatments that rely on medication, this approach uses cognitive exercises to enhance brain function, making it a non-invasive option for rehabilitation.
34568Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is cognitive training safe for people with brain injuries?
Research on cognitive training programs like RehaCom and NeuroTrackerX shows they are generally safe, with some reports of mild side effects such as mental fatigue, headache, and eye irritation. These programs have been used successfully in people with brain injuries without significant safety concerns.
35789What data supports the effectiveness of the treatment BrainHQ Cognitive Training Modules for traumatic brain injury?
Research shows that cognitive training programs like RehaCom can improve attention and memory in brain injury patients, with all participants in one study showing better performance after training. Additionally, attention remediation has been found to reduce symptom intensity and improve psychological and social functioning in head injury patients.
12358Eligibility Criteria
This trial is for adults over 18 with a medically documented mild, moderate, or severe traumatic brain injury (TBI) who are at least three months post-injury. It excludes those with schizophrenia, bipolar disorder, or current alcohol/drug abuse to avoid cognitive performance interference.Inclusion Criteria
I am older than 18 years.
I have a medically confirmed traumatic brain injury.
I do not have schizophrenia or bipolar disorder.
Exclusion Criteria
I am under 18 years old.
Participant Groups
The study tests if computerized cognitive remediation can improve working memory and attention in TBI patients. It involves BrainHQ Cognitive Training Modules compared to social awareness tasks in a control group. Assessments occur before training, immediately after, and one month later.
2Treatment groups
Experimental Treatment
Group I: BrainHQ People Skills ArmExperimental Treatment1 Intervention
Participants will be randomized into the BrainHQ People Skills Modules which are 45 minute training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked tocomplete the training in a quiet space and time to complete these activities. Participants will complete the 40 training sessions remotely, but will meet with the study team member online prior to beginning the training and right after completing the training.
Group II: BrainHQ Cognitive Training ArmExperimental Treatment1 Intervention
Participants will be randomized into the BrainHQ Cognitive Training modules which are 45 minute training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked if they have a quiet space and noise cancelling headphones. Participants will complete the training protocols remotely and their performance will be tracked. Participants will complete the 40 training sessions remotely, but will meet with the study team member online prior to beginning the training and right after completing the training.
BrainHQ Cognitive Training Modules is already approved in United States, European Union, Canada, Australia, China for the following indications:
🇺🇸 Approved in United States as Cognitive Rehabilitation for:
- Traumatic Brain Injury
- Improvement of cognitive functions such as attention, memory, and executive functions
🇪🇺 Approved in European Union as Cognitive Rehabilitation for:
- Traumatic Brain Injury
- Improvement of cognitive functions such as attention, memory, and executive functions
🇨🇦 Approved in Canada as Cognitive Rehabilitation for:
- Traumatic Brain Injury
- Improvement of cognitive functions such as attention, memory, and executive functions
🇦🇺 Approved in Australia as Cognitive Rehabilitation for:
- Traumatic Brain Injury
- Improvement of cognitive functions such as attention, memory, and executive functions
🇨🇳 Approved in China as Cognitive Rehabilitation for:
- Traumatic Brain Injury
- Improvement of cognitive functions such as attention, memory, and executive functions
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
NYU Langone HealthNew York, NY
Loading ...
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
References
Efficacy of an educationally-based cognitive retraining programme for traumatically head-injured as measured by LNNB pre- and post-test scores. [2019]Traumatic head-injuries have been described as a national 'silent epidemic' (Wall Street Journal) and within the medical rehabilitation field it is becoming increasingly recognized that the care and service needs for this population significantly surpass the typical scope of acute rehabilitation services. From the literature, it is suggested that long-term recovery is contingent upon the person remaining within a structured, therapeutic environment. Cognitive retraining is one such area of therapeutic service. The major goal of an educational retraining programme for traumatically head-injured students is to maximize each individual's potential for independent functioning, which is promoted through improvement in cognitive functioning, social and emotional adjustments and transitional living experiences. The pre- and post-tests results for this were analyzed collectively utilizing standard T-test comparison procedures for groups with correlated means (SPSS 1983). The results of each student were then analysed individually utilizing the procedure described for subjects measured with the LNNB by Knight and Godfrey (1983).
[Training in cognitive functions in neurologic rehabilitation of craniocerebral trauma]. [2006]This study evaluates a new cognitive rehabilitation therapy for patients after severe head injury. In addition to the standard neurological rehabilitation therapy, one group was trained by the Wiener Determinationsgerät (WDT), a second group was treated by the new program REHACOM, while a third group received only conventional neurological rehabilitation therapy. The three groups each consisted of 12 patients; two groups received 20 sessions of training, each lasting 40 minutes. At the beginning as well as after the therapy a psychological test battery was applied, consisting of HAWIE, TULUC, AACHENER APHASIETEST, and BENTON-Test. They were also tested by a specific neuropsychological battery regarding hemispheric specialization. REHACOM showed significantly higher values on the HAWIE as well as on BENTON-Test than the other two groups. REHACOM also improved in right-hemispheric dimensions while WDT group did not improve in attention. Right-hemispheric training was more effective than attentional stimulation.
Remediation of attention deficits in head injury. [2009]Head injury is associated with psychological sequelae which impair the patient's psychosocial functioning. Information processing, attention and memory deficits are seen in head injuries of all severity. We attempted to improve deficits of focused, sustained and divided attention. The principle of overlapping sources of attention resource pools was utilised in devising the remediation programme. Tasks used simple inexpensive materials. Four head injured young adult males with post concussion syndrome underwent the retraining program for one month. The patients had deficits of focused, sustained and divided attention parallel processing, serial processing, visual scanning, verbal learning and memory and working memory. After the retraining programme the deficits of attention improved in the four patients. Serial processing improved in two patients. Parallel processing and neuropsychological deficits did not improve in any patient. The symptom intensity reduced markedly and behavioural functioning improved in three of the four patients. The results supported an association between improving attention and reduction of symptom intensity. Attention remediation shows promise as a cost effective, time efficient and simple technique to improve the psychological and psychosocial functioning of the head injured patient.
Cognitive rehabilitation in traumatic brain injury. [2021]Traumatic brain injury (TBI) is a major public health problem with neurobehavioral sequelae contributing to the long-term disability that is often associated with the moderate to severe levels of injury. Rehabilitation of cognitive skills is central to encouraging the full participation of the individual in home, vocational, and social roles. The review of available evidence points to four major recommendations for the rehabilitation of cognition following brain injury: 1) Access to subacute rehabilitation that is holistic in nature and involves a multidisciplinary or transdisciplinary team to work in an integrated fashion to support physical, cognitive, and social skill retraining is vital to support positive outcome following TBI. The collaborative effort of these individuals allows for continual reinforcement and evaluation of treatment goals and will often involve the family and/or important others in the individual's life to prepare for community re-entry. 2) Trials of medication, especially methylphenidate, to assist individuals with significant attention and memory impairment appear well supported by the available evidence. Though some data suggest that the use of cholinesterase inhibitors may be of use for individuals with memory impairments, there is less support for this practice and there are indications that it may worsen the behavioral sequelae of the injury. 3) Randomized controlled trials demonstrate the utility of specific rehabilitation approaches to attention retraining and retraining of executive functioning skills. Future research is needed on rehabilitation techniques in other domains of cognition. 4) Training in the use of supportive devices (either a memory book or more technologically enhanced compensatory devices) to support the individual's daily activities remains central to the independent function of the individual in the community. Though emerging treatments (eg, virtual reality environments) show relative degrees of promise for inclusion in the rehabilitation of the individual with TBI, these need further evaluation in systematic trials.
Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]We describe the clinical impact of the RehaCom computerized cognitive training program instituted in the International Neurological Restoration Center for rehabilitation of brain injury patients. Fifty patients admitted from 2008 through 2010 were trained over 60 sessions. Attention and memory functions were assessed with a pre- and post-treatment design, using the Mini-Mental State Examination, Wechsler Memory Scale and Trail Making Test (Parts A and B). Negative effects were assessed, including mental fatigue, headache and eye irritation. The program's clinical usefulness was confirmed, with 100% of patients showing improved performance in trained functions.
Cognitive Impairment and Rehabilitation Strategies After Traumatic Brain Injury. [2022]Traumatic brain injury (TBI) is among the significant causes of morbidity and mortality in the present world. Around 1.6 million persons sustain TBI, whereas 200,000 die annually in India, thus highlighting the rising need for appropriate cognitive rehabilitation strategies. This literature review assesses the current knowledge of various cognitive rehabilitation training strategies. The entire spectrum of TBI severity; mild to severe, is associated with cognitive deficits of varying degree. Cognitive insufficiency is more prevalent and longer lasting in TBI persons than in the general population. A multidisciplinary approach with neuropsychiatric evaluation is warranted. Attention process training and tasks for attention deficits, compensatory strategies and errorless learning training for memory deficits, pragmatic language skills and social behavior guidance for cognitive-communication disorder, meta-cognitive strategy, and problem-solving training for executive disorder are the mainstay of therapy for cognitive deficits in persons with TBI. Cognitive impairments following TBI are common and vary widely. Different cognitive rehabilitation techniques and combinations in addition to pharmacotherapy are helpful in addressing various cognitive deficits.
Cognitive Effects of ThinkRx Cognitive Rehabilitation Training for Eleven Soldiers with Brain Injury: A Retrospective Chart Review. [2020]Cognitive rehabilitation training is a promising technique for remediating the cognitive deficits associated with brain injury. Extant research is dominated by computer-based interventions with varied results. Results from clinician-delivered cognitive rehabilitation are notably lacking in the literature. The current study examined the cognitive outcomes following ThinkRx, a clinician-delivered cognitive rehabilitation training program for soldiers recovering from traumatic brain injury and acquired brain injury. In a retrospective chart review, we examined cognitive outcomes of 11 cases who had completed an average of 80 h of ThinkRx cognitive rehabilitation training delivered by clinicians and supplemented with digital training exercises. Outcome measures included scores from six cognitive skill batteries on the Woodcock Johnson - III Tests of Cognitive Abilities. Participants achieved gains in all cognitive skills tested and achieved statistically significant changes in long-term memory, processing speed, auditory processing, and fluid reasoning with very large effect sizes. Clinically significant changes in multiple cognitive skills were also noted across cases. Results of the study suggest that ThinkRx clinician-delivered cognitive training supplemented with digital exercises may be a viable method for targeting the cognitive deficits associated with brain injury.
Cognitive and Functional Outcomes following Inpatient Rehabilitation in Patients with Acquired Brain Injury: A Prospective Follow-up Study. [2020]To study the effects of cognitive retraining and inpatient rehabilitation to study the effects of cognitive retraining and inpatient rehabilitation in patients with acquired brain injury (ABI).
A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. [2023]Many traumatic brain injury (TBI) survivors face scheduling and transportation challenges when seeking therapeutic interventions. The COVID-19 pandemic created a shift in the use of at-home spaces for work, play, and research, inspiring the development of online therapeutic options. In the current study, we determined the feasibility of an at-home cognitive training tool (NeuroTrackerX) that uses anaglyph three-dimensional (3D) glasses and three-dimensional multiple object tracking (3D-MOT) software. We recruited 20 adults (10 female; mean age = 68.3 years, standard deviation [SD] = 6.75) as the at-home training group. We assessed cognitive health status for participants using a self-report questionnaire and the Mini-Mental State Examination (MMSE), and all participants were deemed cognitively healthy (MMSE >26). At-home participants loaned the necessary equipment (e.g., 3D glasses, computer equipment) from the research facilities and engaged in 10 training sessions over 5 weeks (two times per week). Participant recruitment, retention, adherence, and experience were used as markers of feasibility. For program validation, 20 participants (10 female; mean age = 63.39 years, SD = 12.22), who had previously completed at least eight sessions of the in-lab 3D-MOT program, were randomly selected as the control group. We assessed individual session scores, overall improvement, and learning rates between groups. Program feasibility is supported by high recruitment and retention, 90% participant adherence, and participants' ease of use of the program. Validation of the program is supported. Groups showed no differences in session scores (p > 0.05) and percentage improvement (p > 0.05) despite the differences in screen size and 3D technology. Participants in both groups showed significant improvements in task performance across the training sessions (p < 0.001). NeuroTrackerX provides a promising at-home option for cognitive training in cognitively healthy adults and may be a promising avenue as an at-home therapeutic for TBI survivors. This abstract was previously published on clinicaltrials.gov and can be found at: https://www.clinicaltrials.gov/ct2/show/NCT05278273.