Clinical trial NCT02507271: Speed of Processing Training in Traumatic Brain Injury
Official title: Speed of Processing Training in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Vascular Accident, Brain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Mild, moderate and severe traumatic brain injury or a cerebral vascular accident (Stroke)
* All subjects will be between the ages of 18 and 70 years
* Free from significant psychiatric history (such as schizophrenia or bipolar disorder), due to the potential influence of such disorders on cognitive functioning
* Free of current alcohol or drug as these factors have been shown to negatively affect cognitive abilities.

Exclusion Criteria:

* Potential participants will be excluded if they are currently taking benzodiazepines or neuroleptics due to their potential effects on cognition.
* Participant will be excluded if they are unable to comprehend the English language, either verbally or written.
* Participants will be excluded from the magnetic resonance imaging (MRI) scan portion of the study if they contain metal in their body that is not compatible with the MRI scan.

Primary outcomes:
measure: Reading ability
timeFrame: Change from baseline after 13 weeks
measure: Speed of Information Processing
timeFrame: Change from baseline after 13 weeks
measure: Executive Functions
timeFrame: Change from baseline after 13 weeks
measure: Working Memory and Attention
timeFrame: Change from baseline after 13 weeks
measure: Visual and Verbal Memory
timeFrame: Change from baseline after 13 weeks
measure: Speech Perception
timeFrame: Change from baseline after 13 weeks
measure: Depression
timeFrame: Change from baseline after 13 weeks
measure: Anxiety
timeFrame: Change from baseline after 13 weeks
measure: Cognitive Questionnaire
timeFrame: Change from baseline after 13 weeks
Secondary outcomes:
measure: Neuroimaging
timeFrame: Change from baseline after 13 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center, Rusk Institute for Rehabilitation
state: New York
Study officials:
affiliation: New York University
name: Gerald Voelbel
role: PRINCIPAL_INVESTIGATOR
References: