Acquired Brain InjuryCCTNCT06130735
Impact of Intensive Computerized Cognitive Training
A study testing Cognitive Computerized Training in people with Acquired Brain Injury and Mild Cognitive Impairment, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Acquired Brain Injury, Mild Cognitive Impairment, Mild Neurocognitive Disorder
- What is being tested?
- Cognitive Computerized Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of the Mass General Brigham Health System with primary attention and executive functioning difficulties and/or a diagnosis of mild cognitive disorder or mild neurocognitive disorder (non-amnestic profile), due to an acquired brain injury (ABI) sustained at least 12 months prior to study contact.
- Ages 25-65 years old
- Proficiency in English
- Willing and able to complete all study-related activities for 12 months, including travel to Brigham and Women's Hospital (Boston) for four in-person assessment visits and two serum and saliva sample collections.
- Access to a computer with webcam and stable internet.
- A reliable study informant who can complete one questionnaire about participant's cognition/daily functioning, at four time points.
Who cannot join
- History of alcohol or substance abuse, or dependence, within the past 2 years, as per DSM-5 criteria.
- High likelihood of an underlying progressive neurodegenerative disorder.
- Evidence of moderate to severe cognitive disorder, based on a score of 21 or less on the Mini-Mental Status Examination (MMSE) (Tombaugh \& McIntyre, 1992).
- Patient Health Questionnaire (PHQ)-9 (Kroenke et al., 2010) Score ≥ 19, unless deemed by treating provider not to have active depression (e.g., adjustment disorder, grief reaction).
- Active psychotic symptoms.
- Severe sensory losses such that participants would unlikely be able to participate in the study training, even with substantial accommodations (self-report of extreme difficulty reading ordinary newspaper print or a performance-tested corrected vision test score of worse than 20/30).
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- Communication difficulties that prevent the participant from effectively participating in this highly interactive study protocol (based on interviewer's rating of a person's ability to be understood and to understand others).
- Current participation in a pharmacological, or other interventional research trial.
- Life expectancy of < 2 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
Read the detailed description
To investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module.
The study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) BDNF levels in blood and salivary, 3) ERP measures of working memory, and 4) resting state fMRI and structural MRI.
- Being tested
- Cognitive Computerized Training
- Keywords
- computerized cognitive training, working memory, acquired brain injury, mild neurocognitive impairment, neuropsychological testing, BDNF, event-related potentials
- Medical subject headings
- Brain Injuries, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Computerized TrainingBehavioural
Participants will log into ABI Wellness Platform five days per week (M-T-W-Th-F) and train using the Symbol Relations module for 45 to 60 minutes. Every other week, participants will meet with their training facilitator via zoom to review training progress and troubleshoot any training-related questions.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Training | Experimental | See section of intervention/treatment for additional information. Receives: Behavioral: Cognitive Computerized Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive outcome measures
We will use age-corrected standard scores of the NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, and individual scores on RAVLT, Verbal Fluency, and Trailmaking Task as cognitive outcome measures.
Measured: 6 months
Changes in BDNF Levels in blood and saliva
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.
Measured: 6 months
Secondary outcomes (9)
Self-report exercise and physical activity
Physical Activity Scale for the Elderly (questionnaire).
Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity.
Measured: 6 months
Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b)
- Measured in response to verbal and visual working memory tasks
Measured: 6 months
Intervention-related changes in resting state fMRI
A group ICA analysis procedure will be applied to pre- and post-intervention rs-fMRI BOLD signal activity. Correlations will be explored between fMRI parameters, cognitive, and training data (e.g NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, Crystallized Composite, CCT engagement and progress).
Measured: 6 months
Quality of life self-report
Flanagan Quality of Life Scale (questionnaire).
Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
Measured: 6 months
Sleep
Medical Outcomes Study Sleep Scale (questionnaire)
Likert scale measuring sleep quality and sleep problems index. 0-60 with greater values representing higher sleep quality and lower sleep problems.
Measured: 6 months
Anxiety
Generalized Anxiety Disorder 7 Item Scale (questionnaire)
Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety.
Measured: 6 months
Depression
Patient Health Questionnaire Depression Scale (questionnaire)
Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression.
Measured: 6 months
Self-report on impact of fatigue
Modified Fatigue Impact Scale
Likert scale on the impact of fatigue on one's physical, cognitive, and psychosocial activity. 0-84 with higher scores indicating a greater impact of fatigue on a person's activities.
Measured: 6 months
Feelings about cognitive/thinking skills
Cognitive Self- Efficacy Questionnaire
Likert scale on feelings people have about their cognition/thinking skills. 0-72 with a higher score indicating more positive feelings regarding the efficacy of ones cognitive/thinking abilities.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Oct 2023
- Primary completion5 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujifilm
- Responsible party
- Principal investigator, Kirk Daffner, MD, Brigham and Women's Hospital
- Investigators
- Kim C Willment, PhD, Principal investigator, Brigham and Women's HospitalKirk R Daffner, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130735
- Sponsor's protocol ID
- 2022P003401
- Acronym
- CCT
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norman A, Curro V, Holloway M, Percuklievska N, Ferrario H. Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review. Disabil Rehabil. 2023 Feb;45(4):739-751. doi: 10.1080/09638288.2022.2043465. Epub 2022 Mar 4.
PubMed 35244507Amariglio RE, Donohue MC, Marshall GA, Rentz DM, Salmon DP, Ferris SH, Karantzoulis S, Aisen PS, Sperling RA; Alzheimer's Disease Cooperative Study. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol. 2015 Apr;72(4):446-54. doi: 10.1001/jamaneurol.2014.3375.
PubMed 25706191Billig AR, Feng NC, Behforuzi H, McFeeley BM, Nicastri CM, Daffner KR. Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia. Cortex. 2020 Dec;133:277-294. doi: 10.1016/j.cortex.2020.09.005. Epub 2020 Sep 24.
PubMed 33157347Biswal BB. Resting state fMRI: a personal history. Neuroimage. 2012 Aug 15;62(2):938-44. doi: 10.1016/j.neuroimage.2012.01.090. Epub 2012 Jan 24.
PubMed 22326802Buckner RL, Krienen FM, Yeo BT. Opportunities and limitations of intrinsic functional connectivity MRI. Nat Neurosci. 2013 Jul;16(7):832-7. doi: 10.1038/nn.3423. Epub 2013 Jun 25.
PubMed 23799476Burckhardt CS, Anderson KL, Archenholtz B, Hagg O. The Flanagan Quality Of Life Scale: evidence of construct validity. Health Qual Life Outcomes. 2003 Oct 23;1:59. doi: 10.1186/1477-7525-1-59.
PubMed 14613563Chen K, Azeez A, Chen DY, Biswal BB. Resting-State Functional Connectivity: Signal Origins and Analytic Methods. Neuroimaging Clin N Am. 2020 Feb;30(1):15-23. doi: 10.1016/j.nic.2019.09.012.
PubMed 31759568Coulter CL, Weber JM, Scarvell JM. Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study. Arch Phys Med Rehabil. 2009 Oct;90(10):1727-33. doi: 10.1016/j.apmr.2009.04.019.
PubMed 19801063Daffner KR, Chong H, Sun X, Tarbi EC, Riis JL, McGinnis SM, Holcomb PJ. Mechanisms underlying age- and performance-related differences in working memory. J Cogn Neurosci. 2011 Jun;23(6):1298-314. doi: 10.1162/jocn.2010.21540. Epub 2010 Jul 9.
PubMed 20617886Kersel DA, Marsh NV, Havill JH, Sleigh JW. Neuropsychological functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Apr;15(4):283-96. doi: 10.1080/02699050010005887.
PubMed 11299130Denboer JW, Nicholls C, Corte C, Chestnut K. National Institutes of Health Toolbox Cognition Battery. Archives of Clinical Neuropsychology. 2014; 29(7): 692-694
Hays RD, Stewart AL. Measuring functioning and well-being: The Medical Outcomes Study Approach. Duke University Press. 1992.
Holloway M, Tasker R. The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services. Journal of Long-term Care. 2019, p.99-110
Ivnik RJ, Malec JF, Smith GE, Tangalos EG, Petersen, RC. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE Token, WRAT-R Reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist. 1996; 10(3): 262-278.
Jones JM, Haslam SA, Jetten J, Williams WH, Morris R, Saroyan S. That which doesn't kill us can make us stronger (and more satisfied with life): the contribution of personal and social changes to well-being after acquired brain injury. Psychol Health. 2011 Mar;26(3):353-69. doi: 10.1080/08870440903440699.
PubMed 20419563
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06130735
- Acronym / sponsor ID
- CCT / 2022P003401
- Keywords
- computerized cognitive training, working memory, acquired brain injury, mild neurocognitive impairment, neuropsychological testing, BDNF, event-related potentials
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Fujifilm
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Nov 2023 (actual)
- 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.
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
Detailed description
To investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module.
The study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) BDNF levels in blood and salivary, 3) ERP measures of working memory, and 4) resting state fMRI and structural MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm.
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training | Experimental | Behavioral: Cognitive Computerized TrainingSee section of intervention/treatment for additional information. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of the Mass General Brigham Health System with primary attention and executive functioning difficulties and/or a diagnosis of mild cognitive disorder or mild neurocognitive disorder (non-amnestic profile), due to an acquired brain injury (ABI) sustained at least 12 months prior to study contact.
- Ages 25-65 years old
- Proficiency in English
- Willing and able to complete all study-related activities for 12 months, including travel to Brigham and Women's Hospital (Boston) for four in-person assessment visits and two serum and saliva sample collections.
- Access to a computer with webcam and stable internet.
Key exclusion criteria (9 listed)
- History of alcohol or substance abuse, or dependence, within the past 2 years, as per DSM-5 criteria.
- High likelihood of an underlying progressive neurodegenerative disorder.
- Evidence of moderate to severe cognitive disorder, based on a score of 21 or less on the Mini-Mental Status Examination (MMSE) (Tombaugh \& McIntyre, 1992).
- Patient Health Questionnaire (PHQ)-9 (Kroenke et al., 2010) Score ≥ 19, unless deemed by treating provider not to have active depression (e.g., adjustment disorder, grief reaction).
- Active psychotic symptoms.
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 |
|---|---|---|
| Cognitive Computerized TrainingParticipants will log into ABI Wellness Platform five days per week (M-T-W-Th-F) and train using the Symbol Relations module for 45 to 60 minutes. Every other week, participants will meet with their training facilitator via zoom to review training progress and troubleshoot any training-related questions. | Behavioural | Computerized Cognitive Training |
Primary outcome
Changes in cognitive outcome measures
Time frame: 6 months
We will use age-corrected standard scores of the NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, and individual scores on RAVLT, Verbal Fluency, and Trailmaking Task as cognitive outcome measures.
Changes in BDNF Levels in blood and saliva
Time frame: 6 months
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.
9 secondary outcomes
Self-report exercise and physical activity
Time frame: 6 months
Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b)
Time frame: 6 months
Intervention-related changes in resting state fMRI
Time frame: 6 months
Quality of life self-report
Time frame: 6 months
Sleep
Time frame: 6 months
Anxiety
Time frame: 6 months
Depression
Time frame: 6 months
Self-report on impact of fatigue
Time frame: 6 months
Feelings about cognitive/thinking skills
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 35244507Norman A, Curro V, Holloway M, Percuklievska N, Ferrario H. Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review. Disabil Rehabil. 2023 Feb;45(4):739-751. doi: 10.1080/09638288.2022.2043465. Epub 2022 Mar 4.
- Background: PubMed 25706191Amariglio RE, Donohue MC, Marshall GA, Rentz DM, Salmon DP, Ferris SH, Karantzoulis S, Aisen PS, Sperling RA; Alzheimer's Disease Cooperative Study. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol. 2015 Apr;72(4):446-54. doi: 10.1001/jamaneurol.2014.3375.
- Background: PubMed 33157347Billig AR, Feng NC, Behforuzi H, McFeeley BM, Nicastri CM, Daffner KR. Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia. Cortex. 2020 Dec;133:277-294. doi: 10.1016/j.cortex.2020.09.005. Epub 2020 Sep 24.
- Background: PubMed 22326802Biswal BB. Resting state fMRI: a personal history. Neuroimage. 2012 Aug 15;62(2):938-44. doi: 10.1016/j.neuroimage.2012.01.090. Epub 2012 Jan 24.
- Background: PubMed 23799476Buckner RL, Krienen FM, Yeo BT. Opportunities and limitations of intrinsic functional connectivity MRI. Nat Neurosci. 2013 Jul;16(7):832-7. doi: 10.1038/nn.3423. Epub 2013 Jun 25.
- Background: PubMed 14613563Burckhardt CS, Anderson KL, Archenholtz B, Hagg O. The Flanagan Quality Of Life Scale: evidence of construct validity. Health Qual Life Outcomes. 2003 Oct 23;1:59. doi: 10.1186/1477-7525-1-59.
- Background: PubMed 31759568Chen K, Azeez A, Chen DY, Biswal BB. Resting-State Functional Connectivity: Signal Origins and Analytic Methods. Neuroimaging Clin N Am. 2020 Feb;30(1):15-23. doi: 10.1016/j.nic.2019.09.012.
- Background: PubMed 19801063Coulter CL, Weber JM, Scarvell JM. Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study. Arch Phys Med Rehabil. 2009 Oct;90(10):1727-33. doi: 10.1016/j.apmr.2009.04.019.
- Background: PubMed 20617886Daffner KR, Chong H, Sun X, Tarbi EC, Riis JL, McGinnis SM, Holcomb PJ. Mechanisms underlying age- and performance-related differences in working memory. J Cogn Neurosci. 2011 Jun;23(6):1298-314. doi: 10.1162/jocn.2010.21540. Epub 2010 Jul 9.
- Background: PubMed 11299130Kersel DA, Marsh NV, Havill JH, Sleigh JW. Neuropsychological functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Apr;15(4):283-96. doi: 10.1080/02699050010005887.
- BackgroundDenboer JW, Nicholls C, Corte C, Chestnut K. National Institutes of Health Toolbox Cognition Battery. Archives of Clinical Neuropsychology. 2014; 29(7): 692-694
- BackgroundHays RD, Stewart AL. Measuring functioning and well-being: The Medical Outcomes Study Approach. Duke University Press. 1992.
- Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping reviewLink provided by the sponsor.
- Tracking early decline in cognitive function in older individuals at risk for Alzheimer's disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function InstrumentLink provided by the sponsor.
- Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementiaLink provided by the sponsor.
- Resting state fMRI: a personal historyLink provided by the sponsor.
- Opportunities and limitations of intrinsic functional connectivity MRILink provided by the sponsor.
- The Flanagan Quality Of Life Scale: evidence of construct validityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kim C Willment, PhD principal investigator
Brigham and Women's Hospital
Kirk R Daffner, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Computerized Training in people with Acquired Brain Injury and Mild Cognitive Impairment, run by Brigham and Women's Hospital 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in cognitive outcome measures (time frame: 6 months). The study lists 2 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 NCT06130735, which also lists 41 linked publications.
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 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.