NYU Langone Medical Center, Rusk Institute for Rehabilitation
New York, 10016, United States
NCT Number: NCT02507271
The purpose of this project is to test the hypothesis that Speed of Information Processing (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals with acquired brain injuries have speed of information processing deficits as part of the cognitive sequelae of the brain injury. Empirical research is expected to demonstrate the efficacy of computerized cognitive Speed of Information Processing (SIP) training in individuals with ABI.
Study participants will be asked to attend two study visits over the course of approximately 13 weeks. Participants will be randomly assigned to either the experimental or control group.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
New York, 10016, United States
The specific aims of the current research protocol are as follows: Aim 1: To test the hypothesis that SIP training of individuals with ABI will improve processing speed. This study is expected to demonstrate that individuals with ABI that receive SIP training will improve on neurocognitive measures of processing speed. Aim 2: To test the generalizability of SIP training of individuals with TBI to other cognitive domains beyond information processing speed. This study is expected to demonstrate increases in working memory, attention and executive functioning in the group that receives the cognitive training. Aim 3: To test the hypothesis that SIP training of individuals with TBI will improve mood. This study is expected to demonstrate that self-reported levels of depression will improve in the group that receives cognitive training. Aim 4: To examine if changes in the neural integrity of white matter pathways of the brain occur in individuals that undergo the SIP training.
All participants will undergo a set of baseline cognitive exams/tests, which will take approximately two hours. Participants will be randomly placed in either the experimental group or the control group. The experimental group will undergo approximately 40 hours of training on the Brain Fitness Program over an eight week period. The control group will be contacted once a week for eight weeks about their cognitively stimulating activities (i.e. reading, working on the computer, and puzzles). At approximately the thirteenth week participants from both groups will undergo post-baseline cognitive exams/tests. This evaluation will take approximately two hours. In addition there is an optional neuroimaging study which participants may elect to participate in. Participants who agree to take part in the neuroimaging portion of the study will undergo a baseline MRI scan. At approximately 13 weeks later participants will undergo a post-baseline MRI scan. Both scans will take approximately one hour.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention involves work on a computer by responding to sounds for five hours a week, approximately one hour a day five days a week at the Rusk Institute for Rehabilitation.
This intervention involves weekly telephone calls over a period of approximately 8 weeks to inquire about the participant's involvement in cognitively stimulating activities (such as reading, working on the computer, puzzles, etc.)
Time frame: Change from baseline after 13 weeks
Wechsler Test of Adult Reading (WTAR). The WTAR is a measure that reliably estimates levels of intelligence by asking the participant to read aloud the words on an established reading list.
Time frame: Change from baseline after 13 weeks
Time frame: Change from baseline after 13 weeks
Time frame: Change from baseline after 13 weeks
Time frame: Change from baseline after 13 weeks
Verbal memory will be assessed with the Verbal Memory subtest of the CNS- Vital Signs neurocognitive battery. Participants will learn a list of words and then will be assessed for immediate recall and delayed recall.
Time frame: Change from baseline after 13 weeks
Participants will be given a hearing screening which will take approximately 5 minutes. Participants will listen to speech sounds, words, or sentences over headphones and will make judgments about what they hear, by speaking a response, pushing a button, typing a response, or touching a computer screen. They will either be asked to make judgments about what they hear (e.g., what was the word) or the voice of the person who spoke.
Time frame: Change from baseline after 13 weeks
Beck Depression Inventory -II: This is a standardized instrument for the assessment of depression with a self-report questionnaire. Participants will endorse the level of disturbance which best describe their mood over 21 items that are characteristic of depression
Time frame: Change from baseline after 13 weeks
Beck Anxiety Inventory: The BAI is a self-report instrument for the assessment of anxiety. The BAI consists of 21 items, each describing a common symptom of anxiety on which the respondent rates how much they have been bothered by the symptoms over the last week
Time frame: Change from baseline after 13 weeks
The Cognitive Self-Report Questionnaire assesses perceptions of cognitive abilities). The Cognitive Self-Report Questionnaire consists of 25 statements about cognition and mood in everyday life over the past 2 weeks.
Time frame: Change from baseline after 13 weeks
This is an optional procedure for study participants. Participants who wish to participate will undergo a resting state functional MRI (fMRI), a structural MRI sequence and a Diffusion Tensor Imaging (DTI) sequence at baseline and post-baseline. The neuroimaging component is to examine if the neural pathways involved with processing verbal information improve following the Brain Fitness Program training.
NYU Langone Health
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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