Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury

This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled
clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized
cognitive remediation treatment versus a computer-based control. Both the study and the
cognitive remediation treatments meet the criteria of Non-Significant Risk.

Inclusion Criteria:

1. Subjects must be 18 - 50 years of age at the time of consent

2. Subjects must have a diagnosis of mTBI

3. Subjects must have persistent cognitive dysfunction confirmed by an objective measure
(as recommended by the ICD-10 definition for post-concussion syndrome) or a
subjective measure (as recommended by the DSV-IV definition of post-concussional
disorder).

4. Subjects must be at least three months out from their most recent TBI, concussion,
and/or blast exposure to minimize the effects of spontaneous recovery, as verified
through participant interview.

5. Subjects must be fluent English speakers.

6. Subjects must have adequate sensorimotor capacity to perform the program in the
judgment of the consenting clinician.

Exclusion Criteria:

1. Subjects must not have a history of penetrating head wounds or a diagnosis of
moderate or severe TBI.

2. Subjects must not be in-patients.

3. Subjects must not have a diagnosis of an illness or condition with known cognitive
consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).

4. Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity
Rating Scale (C-SSRS).

5. Subjects must now show signs of intoxication due to current substance abuse
(including alcohol and/or illegal drugs) during any in person visit.

6. Subjects must not have clinically significant visual field deficits noted by the
consenting staff member by direct observation or by medical history.

7. Subjects must not be judged to be lacking effort.

8. Subjects must not have problems performing assessments or comprehending or following
spoken instructions.

9. Subjects must not be enrolled in a concurrent clinical trial involving an
investigational pharmaceutical, nutraceutical, medical device, or behavioral
treatment for TBI that could affect the outcome of this study.