RECRUITING

Impact of Intensive Computerized Cognitive Training

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Conditions

Acquired Brain InjuryMild Cognitive ImpairmentMild Neurocognitive Disordercomputerized cognitive trainingworking memorymild neurocognitive impairmentneuropsychological testingBDNFevent-related potentials

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury

Quick Facts

Study Start:2023-10-01
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06130735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Ages 25-65 years old
  3. * Proficiency in English
  4. * 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.
  5. * Access to a computer with webcam and stable internet.
  6. * A reliable study informant who can complete one questionnaire about participant's cognition/daily functioning, at four time points.
  1. * History of alcohol or substance abuse, or dependence, within the past 2 years, as per DSM-5 criteria.
  2. * High likelihood of an underlying progressive neurodegenerative disorder.
  3. * 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).
  4. * 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).
  5. * Active psychotic symptoms.
  6. * 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).
  7. * 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).
  8. * Current participation in a pharmacological, or other interventional research trial.
  9. * Life expectancy of \< 2 years.

Contacts and Locations

Study Contact

George-Ryan Ghorayeb, MA
CONTACT
347-714-2577
gghorayeb@bwh.harvard.edu
Kayla M Riera, BS
CONTACT
781-520-0799
kriera@bwh.harvard.edu

Principal Investigator

Kim C Willment, PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Kirk R Daffner, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Kim C Willment, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
  • Kirk R Daffner, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2024-10-01

Terms related to this study

Keywords Provided by Researchers

  • computerized cognitive training
  • working memory
  • acquired brain injury
  • mild neurocognitive impairment
  • neuropsychological testing
  • BDNF
  • event-related potentials

Additional Relevant MeSH Terms

  • Acquired Brain Injury
  • Mild Cognitive Impairment
  • Mild Neurocognitive Disorder