💬In plain words
What the trial is, and whether it could suit you
The proposed study tests the efficacy (Phase II) of 36 or 54 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve working memory, processing speed and attention in mTBI patients rapidly and effectively to provide clinical testing of a therapeutic training for the remediation of cognitive 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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Referred by Clinician verifying that patient has an mTBI (also includes moderate TBI: those who had a severe TBI with a loss of consciousness more than 30 minutes that is now an mTBI) and has a visual working memory loss as determined by first neuropsychological pre-test administered: The Test of Information Processing Skills (TIPS),
2. One or more concussions,
3. Any loss of consciousness from 5- 30 min (not longer than 30 min) to be in mTBI group, otherwise in moderate TBI group.
4. Any loss of memory for events immediately before or after the accident for 24 hours is in mTBI group, otherwise is in moderate TBI group,
5. Any alteration of mental state at the time of the accident (e.g. feeling dazed, disoriented, or confused),
6. Be between the ages of 18 to 60 years, when development and aging are not factors,
7. Agrees to complete the study after hearing the time commitment involved,
8. Has corrected 20/20 visual acuity, and normal motor control so can do PATH neurotraining (signal direction that dim gray stripes move by pushing arrow keys on the computer),
9. Can sign and understand the informed consent form themself,
10. Can drive to test sites or capable of using public transportation (bus or train) to test site.
11. Reads English fluently, so can follow instructions.
Exclusion Criteria:
1. mTBI occurred less than 3 months earlier \[While post-concussive symptoms (PCS) resolve within days post injury in the majority of individuals with mTBI,127 symptoms can endure 3 months post injury or longer, indicating spontaneous recovery and chronic sequela.128 In the general public, between 8% to 33% of mTBI patients have persistent PCS and long-term cognitive and/or behavioral impairments129 that negatively impact quality of life. In the proposed study, we will try to minimize the confound from the spontaneous recovery by only recruiting chronic mTBI subjects, and not recruiting mTBI subjects with mTBI less than 3 months.\] with no maximum time if still experiencing memory problems which will be measured by the TIPS visual working memory (VWM) scores.
2. diagnosis of epilepsy or seizure disorder in last 12 months,
3. diagnosis of moderate depressive disorder or moderate anxiety, having driving limitations in traffic
4. answers 'Yes' to any of the questions on the Columbia Suicide Severity Rating Scale,
5. had a stroke or metabolic derangements causing cognitive impairments, i.e. alcohol or substance abuse,
And for those chosen to undergo MEG exams:
6. 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
7. has claustrophobia since MRI scanner is in small enclosed space,
8. has a cardiac pacemaker, or 9) is pregnant.
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