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Active, Not Recruiting

NCT Number: NCT06130735

Impact of Intensive Computerized Cognitive Training

To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

cognitive computerized training

Behavioral

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.

Primary outcomes

  1. 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.

  2. Changes in BDNF Levels in blood and saliva

    Time frame: 6 months

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

Secondary outcomes

  1. Self-report exercise and physical activity

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    • Measured in response to verbal and visual working memory tasks
  3. Intervention-related changes in resting state fMRI

    Time frame: 6 months

    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).

  4. Quality of life self-report

    Time frame: 6 months

    Flanagan Quality of Life Scale (questionnaire).

    Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.

  5. Sleep

    Time frame: 6 months

    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.

  6. Anxiety

    Time frame: 6 months

    Generalized Anxiety Disorder 7 Item Scale (questionnaire)

    Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety.

  7. Depression

    Time frame: 6 months

    Patient Health Questionnaire Depression Scale (questionnaire)

    Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression.

  8. Self-report on impact of fatigue

    Time frame: 6 months

    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.

  9. Feelings about cognitive/thinking skills

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Fujifilm

Registry information

Official study title

Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury

Acronym: CCT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 14, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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