N/A
N=35
Neural Bases of Cognitive Rehabilitation for Brain Injury
Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01120756 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions — 0.26; .01 Change to Z (composite) score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Goal-oriented attentional self-regulation (Behavioral); Brain Health Education (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions |
0.26; .01 | — |
| SECONDARY Functional Evaluations: Change From Baseline on the Goal Processing Scale |
1.05; .01 | — |
Summary
Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.
Eligibility Criteria
Inclusion Criteria
Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).
Exclusion Criteria
- Severely apathetic/abulic
- aphasic
- or other reasons for patients being unable or unwilling to participate with the training tasks
- severe cognitive dysfunction
- history of neurodevelopmental abnormalities
- ongoing illicit drug or alcohol abuse (AUDIT>8)
- severe depression as measured by Beck Depression Inventory (>29)
- severe PTSD precluding participation in research activities (such as group training or MRI scanning)
- There will be no restriction in regard to gender, race and socioeconomic status.
Data sourced from ClinicalTrials.gov (NCT01120756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.