Abstract
BackgroundSpatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients’ overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients’ non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes.Methods/DesignWe will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects.DiscussionThe strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as functional outcomes, and incorporates a large sample size (relative to other neglect treatment studies) in an RCT design.Trial registrationClinicalTrials.gov identifier, NCT01965951
Highlights
Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care
The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as functional outcomes, and incorporates a large sample size in an randomized controlled trial (RCT) design
The current RESPONSE protocol will help determine whether Tonic and phasic alertness treatment (TAPAT) is effective in creating lasting deficit reduction and functional improvements and will potentially provide the building blocks for the further development and dissemination of this treatment, leading to an improved standard of care for neglect
Summary
Despite experimentation with dozens of treatments for spatial neglect over the last 50 years [49], there still does not exist an effective, widely accepted treatment approach for this severely debilitating disorder. The current RESPONSE protocol will help determine whether TAPAT is effective in creating lasting deficit reduction and functional improvements and will potentially provide the building blocks for the further development and dissemination of this treatment, leading to an improved standard of care for neglect. The current study is blinded and deals with appropriate allocation concealment. This protocol will measure immediate as well as lasting benefits of treatment. RESPONSE will have one of the largest sample sizes of neglect treatments studies, with an aim of 114 participants. CC and SD helped with manuscript preparation and SD assisted in past and current neglect research studies, study coordination and data management.
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