Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, TBI, Brain Injury
Brief summary
This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).
Detailed description
This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.
Interventions
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
Sponsors
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Study staff conducting baseline and follow-up assessments will be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Sustained a moderate-to-severe TBI at least one year prior to assessment * Fluent in English * Demonstrate impairment in strategic cognitive abilities
Exclusion criteria
* Significant neurological history other than TBI * Significant psychiatric history (e.g., bipolar disorder, schizophrenia) * Significant substance abuse history * Steroid and/or benzodiazepine use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Tolerability Assessment Scale | baseline through final follow-up assessment (16 weeks) | visual analog scale to assess participants' tolerability of intervention |
| Recruitment rate percentage | phone screen to in-person screen (within 2 weeks) | percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen |
| Retention rate percentage | baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks) | adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in time monitoring & time-based prospective memory | 16 weeks | Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance. |
| Changes in strategic cognitive functions (performance on NIH EXAMINER) | 16 weeks | Via the NIH EXAMINER, a comprehensive computerized battery of tests designed to assess strategic cognitive functioning, particularly related to executive functions and related domains. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErica Weber, PhD
Kessler Foundation
Outcome results
None listed