N/A N=18 Randomized Double-blind Treatment

Brain Markers of Improvements in Cognitive Functioning

TBI (Traumatic Brain Injury) · Brain Injuries · Stress · Attention Deficit · Executive Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT03490110 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery — 0.18; -0.06 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: State regulation skill training (Behavioral); Treatment-as-usual (Other)
Age: Adult · 21+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery	0.49; -0.13	—
PRIMARY Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery	0.49; -0.13	—
SECONDARY Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)	1.55; -0.42; 2.27; 0.32	—
SECONDARY Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)	0.56; -0.07; 1.41; 0.60	—
SECONDARY Network Modularity From EEG	0.001; -0.002	—

Summary

Some of the most common, persistent, and disabling consequences of traumatic brain injury affect an individual's ability to achieve personal goals. Interventions that strengthen abilities such as being able to concentrate, remember, stay calm and overcome challenges, could have far reaching benefits for Veterans. One challenge in rehabilitation is that response to training can be highly variable, and a better understanding of the neural bases for this variability could inform care. This pilot project will test the clinical behavioral effects of a cognitive skill training intervention and explore to what extent changes in markers of the brain's electrical activity (using the non-invasive technique of electroencephalograms, EEG) can explain differences in responses to skill training.

Eligibility Criteria

Inclusion Criteria

Veterans
History of TBI (as defined by the American Congress of Rehabilitation Medicine and VA, with reported plausible mechanism of head injury, loss of consciousness with some period of posttraumatic alteration in cognition), in the chronic, stable phase of recovery (>6 months from injury)
On stable psychoactive medications (> 30 days)
Able and willing to participate in EEG, training and, assessments

Exclusion Criteria

Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate with the training tasks
Severe cognitive dysfunction
History of neurodevelopmental abnormalities
Ongoing illicit drug or alcohol abuse
Schizophrenia
Bipolar disorder
History of other neurological disorders
Current medical illnesses that may alter mental status or disrupt participation in the study
Active psychotropic medication changes
There will be no restriction in regard to gender, race, and socioeconomic status

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03490110). 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.