Traumatic Brain InjuryNCT02507271
Speed of Processing Training in Traumatic Brain Injury
A study testing Brain Fitness Program and Weekly Telephone Contact in people with Traumatic Brain Injury and Vascular Accident, Brain, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury, Vascular Accident, Brain
- What is being tested?
- Brain Fitness Program and Weekly Telephone Contact
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2010to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center, Rusk Institute for Rehabilitation
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Vascular Accident, Brain
- Being tested
- Brain Fitness Program, Weekly Telephone Contact
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Fitness ProgramOther
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.
Weekly Telephone ContactOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: Brain Fitness Program |
| Control Group | Placebo comparator | Not described Receives: Other: Weekly Telephone Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading ability
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.
Measured: Change from baseline after 13 weeks
Speed of Information Processing
- The Paced Auditory Serial Addition Test (PASAT), which is designed to assess complex mental manipulation by adding the two most recent numbers that are presented auditorily. 2) The Symbol Digit Coding subtest of the CNS-Vital Signs neurocognitive battery, which requires the examinee to type and respond as quickly as possible the appropriate number that matches the special symbol. 3) The Stroop subtest of the CNS-Vital Signs neurocognitive battery: The Stroop Test has three parts to it. A) Read the word that is a name of a color as quickly as possible within 90 seconds. B) Name the color of ink that four X's as quickly as possible within 90 seconds. C) Name the color of the ink that the word is written in. The word is a color of ink that is incongruent to the color of the print. The participant is required to name as many inks as possible within 90 seconds.
Measured: Change from baseline after 13 weeks
Executive Functions
- Trail Making Test, Part A \& B: This test measures efficiency of visual search and set shifting while alternating between letters and numbers. 2) Wisconsin Card Sorting Test, this test measures mental flexibility, set shifting and hypothesis testing. 3) The Non-Verbal Reasoning subtest of the CNS- Vital Signs neurocognitive battery, which is a measure of non-verbal reasoning and pattern identification.
Measured: Change from baseline after 13 weeks
Working Memory and Attention
- The Continuous Performance subtest of the CNS- Vital Signs neurocognitive battery. The Continuous Performance test assesses sustained attention and reaction time to targets presented on the computer. 2) The Shifting Attention subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess the participant's ability to maintain attention while switching between sets of target. 3) Four-Parts Continuous performance subtest of the CNS- Vital Signs neurocognitive battery, which is a measure of working memory and sustained attention. In addition to these working memory and attention tasks, a verbal digit-span task, this is a standardized measure of verbal working memory.
Measured: Change from baseline after 13 weeks
Visual and Verbal Memory
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.
Measured: Change from baseline after 13 weeks
Speech Perception
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.
Measured: Change from baseline after 13 weeks
Depression
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
Measured: Change from baseline after 13 weeks
Anxiety
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
Measured: Change from baseline after 13 weeks
Cognitive Questionnaire
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.
Measured: Change from baseline after 13 weeks
Secondary outcomes (1)
Neuroimaging
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.
Measured: Change from baseline after 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study start1 Aug 2010
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Voelbel, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507271
- Sponsor's protocol ID
- 10-01918
- Status last verified
- Mar 2021
- First submitted
- 21 Jul 2015
- Last updated
- 30 Mar 2021
- Results posted
- No
Publications
Lambez B, Vakil E, Voelbel GT. The effects of background factors on working memory and processing speed in auditory processing intervention. Neuropsychol Rehabil. 2026 Jul 28:1-18. doi: 10.1080/09602011.2026.2705980. Online ahead of print.
PubMed 42518288
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speed of Processing Training in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02507271
- Acronym / sponsor ID
- 10-01918
- Conditions
- Traumatic Brain Injury, Vascular Accident, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Brain Fitness Program |
| Control Group | Placebo comparator | Other: Weekly Telephone Contact |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Fitness ProgramThis 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. | Other | Experimental Group |
| Weekly Telephone ContactThis 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.) | Other | Control Group |
Primary outcome
Reading ability
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.
Speed of Information Processing
Time frame: Change from baseline after 13 weeks
1) The Paced Auditory Serial Addition Test (PASAT), which is designed to assess complex mental manipulation by adding the two most recent numbers that are presented auditorily. 2) The Symbol Digit Coding subtest of the CNS-Vital Signs neurocognitive battery, which requires the examinee to type and respond as quickly as possible the appropriate number that matches the special symbol. 3) The Stroop subtest of the CNS-Vital Signs neurocognitive battery: The Stroop Test has three parts to it. A) Read the word that is a name of a color as quickly as possible within 90 seconds. B) Name the color of ink that four X's as quickly as possible within 90 seconds. C) Name the color of the ink that the word is written in. The word is a color of ink that is incongruent to the color of the print. The participant is required to name as many inks as possible within 90 seconds.
Executive Functions
Time frame: Change from baseline after 13 weeks
1) Trail Making Test, Part A \& B: This test measures efficiency of visual search and set shifting while alternating between letters and numbers. 2) Wisconsin Card Sorting Test, this test measures mental flexibility, set shifting and hypothesis testing. 3) The Non-Verbal Reasoning subtest of the CNS- Vital Signs neurocognitive battery, which is a measure of non-verbal reasoning and pattern identification.
Working Memory and Attention
Time frame: Change from baseline after 13 weeks
1) The Continuous Performance subtest of the CNS- Vital Signs neurocognitive battery. The Continuous Performance test assesses sustained attention and reaction time to targets presented on the computer. 2) The Shifting Attention subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess the participant's ability to maintain attention while switching between sets of target. 3) Four-Parts Continuous performance subtest of the CNS- Vital Signs neurocognitive battery, which is a measure of working memory and sustained attention. In addition to these working memory and attention tasks, a verbal digit-span task, this is a standardized measure of verbal working memory.
Visual and Verbal Memory
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.
Speech Perception
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.
Depression
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
Anxiety
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
Cognitive Questionnaire
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.
1 secondary outcome
Neuroimaging
Time frame: Change from baseline after 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 42518288Lambez B, Vakil E, Voelbel GT. The effects of background factors on working memory and processing speed in auditory processing intervention. Neuropsychol Rehabil. 2026 Jul 28:1-18. doi: 10.1080/09602011.2026.2705980. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Voelbel principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Fitness Program and Weekly Telephone Contact in people with Traumatic Brain Injury and Vascular Accident, Brain, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading ability (time frame: Change from baseline after 13 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021; AzTrials last refreshed its copy on 2 Nov 2026.