Impact of Intensive Computerized Cognitive Training

NCT06130735 | Recruiting

• 1 other identifier: 2022P003401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• Changes in BDNF Levels in blood and saliva

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

  6 months

Secondary Outcomes (9)

• Self-report exercise and physical activity

  6 months

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

  6 months

• Intervention-related changes in resting state fMRI

  6 months

• Quality of life self-report

  6 months

• Sleep

  6 months

Study Arms (1)

Computerized Cognitive Training

EXPERIMENTAL

See section of intervention/treatment for additional information.

Behavioral: Cognitive Computerized Training

Interventions

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.

Computerized Cognitive Training

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Fujifilm: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (41)

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Related Links

• Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review
• Tracking early decline in cognitive function in older individuals at risk for Alzheimer's disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument
• Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia
• Resting state fMRI: a personal history
• Opportunities and limitations of intrinsic functional connectivity MRI
• The Flanagan Quality Of Life Scale: evidence of construct validity
• Resting-State Functional Connectivity: Signal Origins and Analytic Methods
• Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study
• Mechanisms Underlying Age- and Performance-related Differences in Working Memory
• National Institutes of Health Toolbox Cognition Battery
• Neuropsychological functioning during the year following severe traumatic brain injury
• The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services
• 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
• Psychosocial functioning during the year following severe traumatic brain injury
• Group dynamics in the rehabilitation of hemiplegic patients
• Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study
• BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults
• The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review
• Modified Fatigue Impact Scale
• Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury
• Resting-state brain networks: literature review and clinical applications
• Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial
• The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue
• The ACTIVE study: study overview and major findings
• The mini-mental state examination: a comprehensive review
• A comparison of the cost-effectiveness of two types of occupational therapy services
• The measurement of participant-reported memory across diverse populations and settings: a systematic review and meta-analysis of the Multifactorial Memory Questionnaire
• Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances
• Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults
• Rey Auditory-Verbal Learning Test: structure analysis
• Cost-effectiveness of cognitive-behavioural therapy and drug interventions for major depression
• Acquired brain injury: combining social psychological and neuropsychological perspectives
• The Physical Activity Scale for the Elderly (PASE): development and evaluation
• Group therapy utilization in inpatient spinal cord injury rehabilitation

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Mental Disorders

Study Officials

• Kim C Willment, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Kirk R Daffner, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George-Ryan Ghorayeb, MA

CONTACT

347-714-2577; gghorayeb@bwh.harvard.edu

Kayla M Riera, BS

CONTACT

781-520-0799; kriera@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cognitive and Behavioral Neurology

Model Details: Clinical trials with a single arm.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 14, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)