PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00927576
First received: June 23, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The investigators will evaluate whether it is possible to improve memory and attention in patients who have suffered traumatic brain injury through the use of at-home computer training. Patients will be issued a computer and will train for three months on tasks that become more challenging as the subjects performance improves. The investigators will evaluate whether the training strengthened mental abilities in general, but evaluating mental abilities in the laboratory before and after testing.


Condition Intervention
Traumatic Brain Injury
Behavioral: Memory training
Behavioral: Executive function training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PC-Based Cognitive Rehabilitation for TBI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in performance on standardized neuropsychological tests [ Time Frame: Tested immediately before and after training, with retention assessed at 6 mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Behavioral: Memory training
Training of visuospatial and verbal memory
Behavioral: Executive function training
Training of executive control functions

Detailed Description:

Here we propose two randomized clinical trials to determine if at-home PC-based adaptive training can improve cognitive function in chronic TBI patients. Both trials will use protocols designed to drive beneficial neuroplastic changes using paradigms similar to those that have shown promising results in smaller scale studies. The first experiment will investigate the effects of training of short-term verbal and spatial memory. 36 patients with chronic mild, moderate and severe TBI will be evaluated with an extensive battery of neuropsychological tests (NPTs) and subjective rating scale measures at study entry. NPT and rating scale data will be compared to those obtained from 100 matched control subjects to characterize the cognitive deficits following mild, moderate and severe TBI. Patients will then be randomly assigned to immediate training (IT) or delayed training (DT) groups in a longitudinal crossover design. IT patients will begin training for 20 min/day on each of three different memory tasks for a period of three months. Training data will be automatically uploaded to monitor daily compliance and learning rate. NPT and rating scale assessments will be obtained midway through the study. Comparisons of changes in trained (IT) and untrained (DT) groups will be used to evaluate training efficacy. Then, during the second phase of the study, the DT group will undergo identical training. Repeat testing at the end of the study will quantify the effects of training on the DT group, and evaluate retention of training benefit in the IT group.

The second experiment will evaluate the effects of training on attention and executive function using a similar randomized trial with a separate group of 36 chronic TBI patents. A comparison of the magnitude of training-related improvements in the two experiments will be used to evaluate specific- and non-specific factors that contribute to training benefit and identify the patient characteristics that are most critical for successful cognitive rehabilitation.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a history of traumatic brain injury.
  • Patients should reside in the Northern California region.

Exclusion Criteria:

  • History of bipolar disorder, mania, or schizophrenia.
  • No current substance abuse.
  • 1-4 yrs post-injury.
  • On stable dosage of any required medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927576

Locations
United States, California
VA Northern California HCS
Martinez, California, United States, 94553
Sponsors and Collaborators
Investigators
Principal Investigator: David L. Woods, PhD VA Northern California HCS
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00927576     History of Changes
Other Study ID Numbers: B6119-R
Study First Received: June 23, 2009
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognitive training
neuroplasticity
cognitive impairment
recovery of function
memory
attention

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014