Intensive Computerized Cognitive Training for Brain Injury Recovery
Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury
This study is testing whether a special computer training program can help people with brain injuries or mild cognitive issues improve their thinking skills over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06130735 on ClinicalTrials.gov |
What this trial studies
This study investigates how intensive computerized cognitive training can enhance cognitive function in individuals with acquired brain injuries or mild neurocognitive disorders. Participants will engage in a 6-month training program using the ABI Wellness BEARS platform, focusing on improving working memory and other cognitive skills. The study will assess changes in neuropsychological performance, brain-derived neurotrophic factor (BDNF) levels, and brain activity through various imaging techniques. The goal is to identify predictors of cognitive enhancement following this intensive training.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-65 with attention and executive functioning difficulties due to an acquired brain injury sustained at least 12 months prior.
Not a fit: Patients with a history of substance abuse or those likely to have a progressive neurodegenerative disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive rehabilitation strategies for patients with brain injuries and cognitive impairments.
How similar studies have performed: Other studies have shown promise in using cognitive training for brain injury recovery, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kim C Willment, PhD — Brigham and Women's Hospital
- Study coordinator: George-Ryan Ghorayeb, MA
- Email: gghorayeb@bwh.harvard.edu
- Phone: 347-714-2577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.