Remediation of Spatial Neglect Trial "RESPONSE"

Completed

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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. Participation is voluntary and participants may withdraw from the study at any time.

Conditions

Interventions

  • TAPAT Other
    Intervention Desc: Tonic and Phasic Alertness Treatment Computerized software training for a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
    ARM 1: Kind: Experimental
    Label: TAPAT
    Description: Tonic and Phasic Alertness Treatment: Computerized software training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
  • Commercially available software Other
    Intervention Desc: Commercially available computerized training. Treatment is software based, will occur up to 39 times throughout study duration, 4-5 times per week.
    ARM 1: Kind: Experimental
    Label: Commerically available software
    Description: Commercially available computerized training. Treatment is software based, will occur up to 39 times throughout study duration, 4-5 times per week.
  • Computerized Plasticity-based Software Other
    Intervention Desc: Tonic and Phasic Alertness Treatment Computerized software training for a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
    ARM 1: Kind: Experimental
    Label: Computerized Plasticity Based Program
    Description: Computerized Plasticity-based software training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
  • Computerized Plasticity-based Adaptive Cognitive Training Other
    Intervention Desc: Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
    ARM 1: Kind: Experimental
    Label: Experimental Treatment
    Description: Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
  • Commercially available computerized training Other
    Intervention Desc: Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.
    ARM 1: Kind: Experimental
    Label: Active Comparator
    Description: Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, one hour each session.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Spatial Attention 6 months No
Secondary Cognitive Performance 6 months No

Sponsors