Impact of Intensive Computerized Cognitive Training (CCT)

Mass General Brigham

Status

Enrolling

Conditions

Mild Neurocognitive Disorder

Mild Cognitive Impairment

Acquired Brain Injury

Treatments

Behavioral: Cognitive Computerized Training

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06130735

2022P003401

Details and patient eligibility

About

To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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.