Summary

for people ages 18-70 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The proposed study tests the feasibility (Phase I) and efficacy (Phase II) of PATH neurotraining to improve working memory and attention in TBI patients rapidly and effectively to provide clinical testing of a therapeutic device for the treatment of neurological disorders caused by a concussion. This study will contribute to the fundamental knowledge of how to remediate concussions from TBIs to enhance the health, lengthen the life and reduce the disabilities that result from a TBI.

Details

The goal of this study is to determine whether working memory and attention improve more in TBI patients after neurotraining that remediates sensory (visual movement) and processing speed functions, improving the motion working range (PATH) more than after no training during Phase I to show its feasibility. During Phase I, standardized tests will be administered three times 12 weeks apart. Half the subjects will do PATH training in the first 12 weeks, having standardized tests administered immediately before and after PATH training, and 12 weeks after training to ensure the results are durable. Half the subjects will be wait-listed, determined randomly, to do no training in the first 12 weeks followed by 12 weeks of PATH training so each of these subjects serves as their own control. Brain training will be done for 20 minutes 3 times a week for 12 weeks, with the task increasing in difficulty as the person improves in their ability to do the task. Once the feasibility of PATH training is shown in Phase I, Phase II will complete the efficacy study to evaluate the impact of PATH training on improving working memory in TBI patients. During Phase II the impact of PATH neurotraining on improving working memory will be evaluated on a much larger sample of TBI patients. During Phase II, not only will a larger number of TBI patients be studied, but each TBI patient will also be followed for 3, 6, 9, and 12 months to determine whether the improvements in attention and working memory are sustained over time. These predictions will be evaluated by both standardized tests and Magnetoencephalography (MEG) brain imaging. MEG brain imaging will be used to determine whether PATH neurotraining improves the function of the dorsal, attention, and working memory networks (e.g., PPC, DLPFC and ACC/PCC areas), reducing over recruitment, more than found after no training during both Phase I and Phase II. MEG imaging will be used to determine whether PATH neurotraining strengthens coupled: 1) theta/gamma activity, and 2) alpha/ gamma activity. Phase II will ascertain the relative advantage(s) of PATH neurotraining for enhancing working memory after a concussion on a much larger sample, showing that these improvements are sustained over time.

Keywords

TBI (Traumatic Brain Injury) Wounds and Injuries Brain Injuries Brain Injuries, Traumatic PATH neurotraining

Eligibility

You can join if…

Open to people ages 18-70

  • Every TBI patient referred by Dr. Lobatz will be included unless the TBI occurred less than 9 months earlier

You CAN'T join if...

  1. Have severe depression or suicidal thoughts or tendencies.
  2. Have had a stroke or metabolic derangements causing cognitive impairments, such as alcohol or substance abuse.
  3. When the TBI occurred had a loss of consciousness for more than 30 minutes.
  4. Cannot complete the PATH neurotraining task, pushing the left or right arrow key on the computer after moving patterns are presented briefly on the computer screen will be excluded. That has never been a problem previously, so we do not anticipate excluding anyone for this reason.
  5. Cannot drive to the test site, eliminating those with major functional issues in cognition.
  6. Do not agree to complete the study after hearing the time commitment involved.
  7. Have extensive metal dental hardware (e.g., braces and large metal dentures; fillings are acceptable) or other metal objects in the head, neck, or face areas that cause artifacts in the MEG data, and are not removable during pre-processing.

Locations

  • University of California at San Diego not yet accepting patients
    San Diego California 92121 United States
  • Perception Dynamics Institute not yet accepting patients
    Solana Beach California 92075 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Perception Dynamics Institute
ID
NCT03655782
Study Type
Interventional
Last Updated
September 1, 2018