Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-10-01
2026-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Computerized Cognitive Training
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
65 Years
ALL
No
Sponsors
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Fujifilm
INDUSTRY
Brigham and Women's Hospital
OTHER
Responsible Party
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Kirk Daffner, MD
Chief, Division of Cognitive and Behavioral Neurology
Principal Investigators
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Kim C Willment, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Kirk R Daffner, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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References
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Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
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Norman A, Curro V, Holloway M, Percuklievska N, Ferrario H. Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review. Disabil Rehabil. 2023 Feb;45(4):739-751. doi: 10.1080/09638288.2022.2043465. Epub 2022 Mar 4.
Coulter CL, Weber JM, Scarvell JM. Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study. Arch Phys Med Rehabil. 2009 Oct;90(10):1727-33. doi: 10.1016/j.apmr.2009.04.019.
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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.
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Holloway M, Tasker R. The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services. Journal of Long-term Care. 2019, p.99-110
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Tulsky DS, Kisala PA. Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances. Arch Phys Med Rehabil. 2022 Feb;103(2):185-190. doi: 10.1016/j.apmr.2021.10.006. Epub 2021 Oct 28.
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Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016.
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Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
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2022P003401
Identifier Type: -
Identifier Source: org_study_id
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