Impact of Intensive Computerized Cognitive Training

Mild Cognitive Impairment Clinical Trial

— CCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130735
• Other study ID #: 2022P003401
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: Brigham and Women's Hospital
• Contact: George-Ryan Ghorayeb, MA
• Phone: 347-714-2577
• Email: gghorayeb[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild Neurocognitive Disorder
• Neurocognitive Disorders

Intervention

Behavioral:
• Cognitive 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Fujifilm

Country where clinical trial is conducted

United States, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in BDNF Levels in blood and saliva	Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Anxiety	Generalized Anxiety Disorder 7 Item Scale (questionnaire); Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety.	6 months
Secondary	Depression	Patient Health Questionnaire Depression Scale (questionnaire); Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression.	6 months
Secondary	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.	6 months
Secondary	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.	6 months

External Links

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