Remediation of Spatial Neglect Trial

N/ACompletedNCT01965951

Posit Science Corporation96 enrolled

Overview

Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning \& memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with acquired brain injury.

Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at participant's convenience (we recommend 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed and again after 3-month no-contact period. Participation is voluntary and participants may withdraw from the study at any time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Interventions

Computerized Plasticity-based Adaptive Cognitive TrainingOTHER

Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, \~30 mins each session.

Commercially available computerized trainingOTHER

Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, \~30 mins each session.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Diagnosis of an acquired brain injury (which may be in the form of a stroke or brain tumor removal) and * Evidence of deficit on at least 2 out of 4 assessment measures of Spatial Neglect: Mesulam Cancelation task (ages 50 and younger \> 0 omissions; 51-80 \> 4 omissions), Dual task (\>19% difference in accuracy for right - left target trials), Tone Counting task (\< 94% total accuracy), or Landmark task (deviation from objective center as determined by the 95% confidence interval, with neglect indicated with 'Y' and no neglect with 'N' following completion of task). * Must be at least 3 months out from their most recent acquired brain injury, stroke, or brain tumor removal * Fluent English speakers * Adequate sensorimotor capacity to participate in the trial, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse Exclusion Criteria: * A conjunction of prior acquired brain injury and score \>8 on Blessed Scale - Short Form * Diagnosis of severe depression (a score of \>29 on Beck Depression Inventory (BDI-II) * Diagnosis of chronic psychiatric disorders with associated cognitive impairments, eg. Schizophrenia * Diagnosis of illness, condition or treatment with known cognitive consequences, eg. chemotherapy * Active Suicidal Ideation with Specific Plan and Intent or any suicide-related behaviors within 2 months of consent * A current or significant past history of substance abuse * Difficulty completing assessments and/or comprehending requirements of trial * Enrollment in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device or behavioral treatment that could affect the outcome of this study * Complete primary visual field deficit, score of 3 on NIH Stroke Scale - Visual Field Subscale

Outcomes

Primary Outcomes

Performance on Posner Cueing Task

Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.

Time frame: At 3 months

Secondary Outcomes

Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)

Between-group magnitude of change in composite score with the measure constructed from Greyscales Task (perceptual bias score) and Spatial Working Memory Task (percent accuracy for targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.