Training in Goal-directed Attention Regulation for Individuals With Brain Injury

Brain Injury Clinical Trial

Official title:

Plasticity in Brain Network to Enhance Cognitive Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035606
• Other study ID #: B4605-I
• Status: Completed
• Phase: N/A
• First received: December 16, 2009
• Last updated: October 18, 2017
• Start date: September 2009
• Est. completion date: April 2017

Study information

• Verified date: October 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.

Description:

Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• history of traumatic brain injury

• greater than 1 week from injury

• residual dysfunction related to attention and executive control

Exclusion Criteria:

• aphasia

• active illicit drug use

• severe depression

• contraindications to MRI scanning

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• training in goal-directed attention regulation
training in goal-directed attention regulation
• brain health education
brain health education workshops
• computer-assisted training in goal-directed attention regulation
computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills

Locations

Country	Name	City	State
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541- — View Citation

Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report	Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.	5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
Secondary	Change From Baseline to Post-training for Task Errors on a Functional Performance Measure	Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).	5 weeks (After completion of Arm 1 and Arm 2)
Secondary	Change to Attention and Executive Functioning Composite Scores	Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3.; Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning.; The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time.	5 weeks (After completion of Arm 1 and Arm 2)

External Links

•   Northern California Institute for Research and Education