Status:
RECRUITING
Impact of Intensive Computerized Cognitive Training
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Fujifilm
Conditions:
Acquired Brain Injury
Mild Cognitive Impairment
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
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 Relatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06130735
Start Date
October 1 2023
End Date
March 1 2026
Last Update
November 5 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115