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

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

Key facts

Study ID

NCT01640158

Run by

Posit Science Corporation

People needed

86

Starts

2013-09-01

Expected to finish

2017-03-02

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be 18 - 50 years of age at the time of consent
• Subjects must have a diagnosis of mTBI
• 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).
• 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.
• Subjects must be fluent English speakers.
• Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.

You may not qualify if…

• Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
• Subjects must not be in-patients.
• Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
• Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
• Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
• Subjects must not be judged to be lacking effort.
• Subjects must not have problems performing assessments or comprehending or following spoken instructions.
• 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.

Where it is running

• Posit Science Corporation — San Francisco, California, United States

Full record on ClinicalTrials.gov

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