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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06130735
Other study ID # 2022P003401
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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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Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756. — View Citation

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Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022. — View Citation

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* Note: There are 41 references in allClick 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
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