CClinicalTrials.gg
Active, not recruitingNCT06130735CCTUpdated Oct 1, 2026

Impact of Intensive Computerized Cognitive Training

An interventional study of Cognitive Computerized Training in Acquired Brain Injury, Mild Cognitive Impairment and Mild Neurocognitive Disorder, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Updated Oct 1, 2026Study completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acquired Brain Injury
  • Mild Cognitive Impairment
  • Mild Neurocognitive Disorder

Keywords

  • computerized cognitive training
  • working memory
  • acquired brain injury
  • mild neurocognitive impairment
  • neuropsychological testing
  • BDNF
  • event-related potentials
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Computerized Cognitive Training

    See section of intervention/treatment for additional information.

    Behavioral: Cognitive Computerized Training

Interventions

  • BehavioralCognitive Computerized Training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. Changes in BDNF Levels in blood and saliva

    Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b)

    1\) Measured in response to verbal and visual working memory tasks

    Time frame: 6 months

  3. 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).

    Time frame: 6 months

  4. 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.

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

  6. Anxiety

    Generalized Anxiety Disorder 7 Item Scale (questionnaire) Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety.

    Time frame: 6 months

  7. Depression

    Patient Health Questionnaire Depression Scale (questionnaire) Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression.

    Time frame: 6 months

  8. 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.

    Time frame: 6 months

  9. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

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  • Amariglio 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 25706191 ↗
  • Billig 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 33157347 ↗
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  • Chen 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 31759568 ↗
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  • Daffner 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 20617886 ↗
  • Kersel 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 11299130 ↗
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  • Kersel DA, Marsh NV, Havill JH, Sleigh JW. Psychosocial functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Aug;15(8):683-96. doi: 10.1080/02699050010013662. PubMed 11485609 ↗
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  • Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756. PubMed 31498125 ↗
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  • Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022. PubMed 36089933 ↗
  • Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7. PubMed 20633738 ↗
  • Porter S, Torres IJ, Panenka W, Rajwani Z, Fawcett D, Hyder A, Virji-Babul N. Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury. Heliyon. 2017 Aug 4;3(8):e00373. doi: 10.1016/j.heliyon.2017.e00373. eCollection 2017 Aug. PubMed 28795168 ↗
  • Retan R, Wolfson D. The Halstead-Reitan neuropsychological test battery: Theory and clinical interpretation. Neuropsychology Press. 1985.
  • Rosazza C, Minati L. Resting-state brain networks: literature review and clinical applications. Neurol Sci. 2011 Oct;32(5):773-85. doi: 10.1007/s10072-011-0636-y. Epub 2011 Jun 11. PubMed 21667095 ↗
  • Schulenberg SE, Yutrzenka BA, Gohm CL. The Computer Aversion, Attitudes, and Familiarity Index (CAAFI): A Measure for the Study of Computer-Related Constructs. Journal of Educational Computing Research. 2006; 34(2): 129-146.
  • Sevick et al. Alterations in Resting State Functional Connectivity in Patients with Traumatic Brain Injury Following a 3-month Pilot Cognitive Intervention Program. Poster Presented at: UBC Department of Psychiatry 2020 Virtual Research Day. 2020.
  • Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455. PubMed 30103334 ↗
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  • Tulsky DS, Kisala PA. Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances. Arch Phys Med Rehabil. 2022 Feb;103(2):185-190. doi: 10.1016/j.apmr.2021.10.006. Epub 2021 Oct 28. PubMed 34756875 ↗
  • Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016. PubMed 27877122 ↗
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Related links

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Study completion
Sep 1, 2026→Dec 1, 2026
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Study completion Sep 1, 2026→Dec 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06130735
Lead sponsor
Brigham and Women's Hospital
Collaborators
Fujifilm
Responsible party
Kirk Daffner, MD (Chief, Division of Cognitive and Behavioral Neurology, Brigham and Women's Hospital) — Principal investigator
First posted
Nov 14, 2023
Start date
Oct 1, 2023
Primary completion
Dec 5, 2025
Completion
Dec 1, 2026 (estimated)
Last update
Oct 1, 2026

Study contacts

Kim C Willment, PhD
principal investigator · Brigham and Women's Hospital
Kirk R Daffner, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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