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Trial record 42 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Improvements in Cognitive Skills From Traumatic Brain Injury Using Dynamic Visual Attention Training

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ClinicalTrials.gov Identifier: NCT03655782
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
University of California, San Diego
University of South Alabama
Information provided by (Responsible Party):
Perception Dynamics Institute

Brief 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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Behavioral: PATH neurotraining Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: During Phase I and Phase II of this study, we will show that working memory and attention improve more in TBI patients after neurotraining that improves sensory and processing speed functions, improving the motion working range (PATH), more than after no training to show its feasibility and efficacy. MEG brain imaging will be used to show that 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Staff will not be told whether the subject was in the treatment or control group. The statistician will not know which group was the treatment group and which was the control group.
Primary Purpose: Treatment
Official Title: Improvements in Cognitive Skills From Traumatic Brain Injury Using Dynamic Visual Attention Training
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PATH neurotraining
Subject looks at computer screen to determine whether bars in fish-shaped window move left or right relative to background bars. The subject reports which way center pattern moves by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes contrast of test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for one training cycle, between 10-20 minutes, 3 times each week for 12 weeks.
Behavioral: PATH neurotraining
Improve visual timing and sensitivity in the dorsal stream.
Other Name: PATH to Insight

No Intervention: No Intervention training
During Phase I 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. During Phase II half the subjects will be randomly assigned to the treatment group and half will be assigned to the control group.



Primary Outcome Measures :
  1. Change in Visual Working Memory [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    The Test of Information Processing Skills Visual Working Memory Standardized Percentile Rank that goes from < 1% to > 99%


Secondary Outcome Measures :
  1. Change in Attention [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    DKEFS Color-Word Interference Test Standardized Percentile Rank for Inhibition subtest going from 0.5% to 99.9%

  2. Change in Cognitive Flexibility [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    DKEFS Color-Word Interference Test standardized scores for Standardized Percentile Rank for Inhibition Switching subtest going from 0.5% to 99.9%

  3. Change in Auditory Working Memory [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    The WAIS Working Memory Index Standardized Percentile Rank that goes from < 0.1% to > 99.9%

  4. Change in Processing Speed [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    WAIS Processing Speed Index Standardized Percentile Rank that goes from < 0.1% to > 99.9%

  5. Change in Reading Speed [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    Number of words/minute subject can read 6 words of text from interesting story using computer-based program.

  6. Change in DLPFC Function [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    Using the total covariance matrix, voxel-wise MEG source magnitude images that cover the whole brain will be obtained for each subject, and each frequency band, following the Fast-VESTAL procedure, measuring time-locked signals during a working memory N-back task to evaluate improvements in brain function in DLPFC (working memory).

  7. Change in ACC Function [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    Using the total covariance matrix, voxel-wise MEG source magnitude images that cover the whole brain will be obtained for each subject, and each frequency band, following the Fast-VESTAL procedure, measuring time-locked signals during a working memory N-back task to evaluate improvements in brain function in ACC (attention network).

  8. Change in Precuneus/PCC [ Time Frame: Immediately before and after 12 weeks of intervention training or no training ]
    Using the total covariance matrix, voxel-wise MEG source magnitude images that cover the whole brain will be obtained for each subject, and each frequency band, following the Fast-VESTAL procedure, measuring time-locked signals during a working memory N-back task to evaluate improvements in brain function in Precuneus/PCC (attention network).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655782


Contacts
Contact: Teri Lawton, Ph.D. 310-903-6009 tlawton@pathtoreading.com
Contact: Ming-Xiong Huang, Ph.D. 858-534-1254 mxhuang@ucsd.edu

Locations
United States, California
University of California at San Diego Not yet recruiting
San Diego, California, United States, 92121
Contact: Ming-Xiong Huang, Ph.D.    858-534-1254    mxhuang@ucsd.edu   
Contact: AnneMarie Angeles, B.S.    858-822-2352    adangeles@ucsd.edu   
Perception Dynamics Institute Not yet recruiting
Solana Beach, California, United States, 92075
Contact: Teri Lawton, Ph.D.    310-903-6009    tlawton@pathtoreading.com   
Contact: Ming-Xiong Huang, Ph.D.    858-534-1254    mxhuang@ucsd.edu   
Sub-Investigator: Ming-Xiong Huang, Ph.D.         
Sponsors and Collaborators
Perception Dynamics Institute
University of California, San Diego
University of South Alabama
Investigators
Principal Investigator: Teri Lawton, Ph.D. Perception Dynamics Institute

Responsible Party: Perception Dynamics Institute
ClinicalTrials.gov Identifier: NCT03655782     History of Changes
Other Study ID Numbers: PerceptionDI
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, deidentified data will be made available to qualified outside investigators following NIH Data Sharing guidelines; none of the data will be considered proprietary. Most of the data for this study will be collected through standardized tests of attention, processing speed, and working memory to be administered by the staff on this project
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: September 2023 for 10 years.
Access Criteria: Qualified investigator

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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