Summary

for people ages 18-55 (full criteria)
healthy people welcome
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 mTBI patients rapidly and effectively to provide clinical testing of a therapeutic training for the treatment of neurological disorders caused by a concussion. This study will contribute to the fundamental knowledge of how to remediate concussions from a mTBI to enhance the health, lengthen the life and reduce the disabilities that result from a mTBI.

Details

This study will provide clinical testing of therapeutic training for the treatment of neurological disorders caused by a concussion. We will extend previous results from a pilot study of 4 mTBI subjects (Lawton & Huang, 2019) to a much larger sample of mTBI subjects. During Phase II we will determine whether these results are sustained over time. The proposed study tests the feasibility (Phase I) and efficacy (Phase II) of PATH neurotraining to improve working memory (primary outcome) and attention (secondary outcome) in mTBI subjects rapidly and effectively. This study will compare PATH training (C.3.1), presenting dim gray patterns moving left or right to activate the dorsal stream (Ungerleider & Mishkin, 1982; Livingstone & Hubel, 1988; Kaplan & Shapley, 1986), with sham training (C.3.2), presenting high contrast colored stationary patterns tilted left or right to activate the parvocells in the ventral stream. We predict that sham training does not improve attention and working memory in mTBI. Healthy controls (no-TBI) will provide baseline data to show that they perform higher on all cognitive tests than do those with a mTBI, and to validate the proper WM network (Menon & Uddin, 2009). Since PATH training must be followed by cognitive exercises to improve cognitive function (Lawton, 2015, 2016), having subjects drive to and from the test site provides cognitive exercises that facilitate improving cognitive function in mTBI. MEG recordings (Huang et al., 2014, 2016, 2018) before and after training will provide a biomarker to determine whether PATH training improves the function of the dorsal, attention, and working memory networks more than found after a sham treatment. MEG recordings will also be used to determine whether PATH training strengthens coupled theta/ gamma activity, and/or alpha/ gamma activity. To increase its commercialization ability, PATH neurotraining must be shown to improve brain function using a biomarker, as stated by neurologists and therapists in letters of support. During Phase II the impact of PATH neurotraining will be evaluated on a larger sample of mTBI subjects and healthy adults. Whether cognitive improvements are sustained over time will be evaluated by measuring whether mTBI subjects improve on neuropsychological tests of cognitive function 3 and 6 months after training.

Keywords

MTBI - Mild Traumatic Brain Injury Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Brain Concussion PATH neurotraining Orientation Discrimination Orientation Discrimination training

Eligibility

For people ages 18-55

An age-matched healthy adult will be included if scores 26-30 on the Montreal Cognitive Assessment (MoCA) screening test unless has any of the exclusion criteria below. A patient with a mTBI who has had a traumatically induced physiologic disruption of brain function will be referred by neurologists Drs. Lobatz and Ho who have made a diagnosis of mTBI, which includes one or more of the following (Marshall et al., 2012):

  1. any loss of consciousness from 5- 30 min (not longer than 30 min),
  2. any loss of memory for events immediately before or after the accident for as much as 24 hours,
  3. any alteration of mental state at the time of the accident (e.g. feeling dazed, disoriented, or confused),
  4. after 30 minutes, Glasgow Coma Scale of 13-15 (not lower or is considered more severe than a mild TBI),
  5. post-traumatic amnesia less than 24 hours,
  6. a score of 19-25 on the Montreal Cognitive Assessment (MoCA) screening test, and
  7. focal neurologic deficits that might/might not be transient.

For this study, the following criteria will be utilized:

Inclusion Criteria:

  1. Diagnosis of mTBI,
  2. between the ages of 18 to 55 years, when development and aging are not factors,
  3. agrees to complete the study after hearing the time commitment involved,
  4. has corrected 20/20 visual acuity, so can do PATH training (dim gray stripes),
  5. reads English fluently, so can follow instructions,
  6. can complete the PATH neurotraining task, by pushing the left or right arrow key on the computer, and
  7. can drive to the test site, so do not have major functional issues in cognition.

Exclusion Criteria:

  1. mTBI occurred less than 9 months earlier,
  2. post-traumatic amnesia longer than 24 hours,
  3. healthy adult has a MoCA score less than 26,
  4. diagnosis of epilepsy or seizure disorder in last 12 months,
  5. diagnosis of major depressive disorder or severe anxiety,
  6. answers 'Yes' to any of the questions on the Columbia Suicide Severity Rating Scale,
  7. had a stroke or metabolic derangements causing cognitive impairments, ie. alcohol or substance abuse,
  8. has extensive metal dental hardware (e.g., braces and large metal dentures; fillings are acceptable) or other metal objects in head, neck, or face areas that cause artifacts in MEG data, and are not removable during pre-processing, and
  9. has claustrophobia since MEG scanner is in small enclosed space.

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