CCT: Impact of Intensive Computerized Cognitive Training

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06130735

Collaborator

Fujifilm (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acquired Brain Injury Mild Cognitive Impairment Mild Neurocognitive Disorder	Behavioral: Cognitive Computerized Training	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Clinical trials with a single arm.Clinical trials with a single arm.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Computerized Cognitive Training See section of intervention/treatment for additional information.	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.

Arm

Intervention/Treatment

Experimental: Computerized Cognitive Training

See section of intervention/treatment for additional information.

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.

Outcome Measures

Primary Outcome Measures

Changes in cognitive outcome measures [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 [6 months]
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.

Secondary Outcome Measures

Self-report exercise and physical activity [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.
Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b) [6 months]
1) Measured in response to verbal and visual working memory tasks
Intervention-related changes in resting state fMRI [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).
Quality of life self-report [6 months]
Flanagan Quality of Life Scale (questionnaire). Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
Sleep [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.
Anxiety [6 months]
Generalized Anxiety Disorder 7 Item Scale (questionnaire) Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety.
Depression [6 months]
Patient Health Questionnaire Depression Scale (questionnaire) Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression.
Self-report on impact of fatigue [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.
Feelings about cognitive/thinking skills [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.