Mild Cognitive Impairment Clinical Trial
— CCTOfficial title:
Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Fujifilm |
United States,
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* Note: There are 41 references in all — Click here to view all references
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 |
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