Standard hand-held mice were provided, with the option for adaptive mice as needed. Noise cancelling headsets were also provided to ensure participants could create an environment that was quiet and undisturbed. For this purpose, laptops with 17” screens were provided, as they allowed for optimal visibility. Technical support, coaching, and monitoring of computer use were completed remotely by a study technician, also detailed below ( Figure 1).įor MS participants, a larger screen size is particularly important to ensure that participants do not have to strain their vision to complete the program. For each of these days, the participant would be required to play half an hour of the program. Based on previous studies, 5, 9, 12 we targeted a 12-week treatment period with the completion of five days of cognitive exercise per week (60 total days played across three months). After receiving instruction from a study technician detailing operation of the laptop and accessing the assigned program, participants were sent home with their study computer and materials. Participants were provided with study equipment that included a laptop computer and accessories, preconfigured to their assigned condition. Participants were also required to fully understand and consent to study procedures, with sufficient visual and motor capacity to operate the study computer equipment.Īfter meeting study eligibility criteria and consenting to study enrollment, participants completed a baseline cognitive evaluation and were randomly assigned to either the active or control game condition. Participants were required to be English speaking and between the ages of 18 and 70 years with a diagnosis of relapsing–remitting MS (RRMS) and no other major medical condition, and stable disease, with the additional requirement of no recent relapse or associated steroid use in the past month. All participants in the pilot study were required to have the same disease-modifying therapy, with all participants recently initiated on fingolimod treatment. We enrolled participants seeking treatment for cognitive impairment due to MS, as judged by their referring neurologist. The primary outcome of this study was feasibility of our cognitive remediation protocol. Here, we describe the features of this protocol and a pilot study of its use. The protocol includes an active control condition with random double-blind assignment to treatment condition. In order to conduct clinical trials that are accessible and feasible to a wide range of individuals living with MS, we have developed a protocol for remotely-supervising the use of a web-based cognitive remediation program delivered to individuals in their homes. However, controlled study is critically needed in order to guide effective use for individuals living with MS. 10, 11 These offer the advantage of a relatively low-cost and easily accessible option. Key components include frequent repetitive learning trials adjusted in real-time to adapt to the user’s ongoing level of performance. 9, 10 There are a variety of programs now available, including some that are directly marketed to individuals with neurological disorders. With rapid technological advances, many web-based cognitive remediation programs are readily available using computers instead of clinicians to administer and drive the training. Nestersoft worktime support trial#5 However, recruitment for this trial took over seven years, possibly due to the constraints of receiving treatment in the clinic. 5 – 7 While there are few adequately-designed clinical trials, meta-analyses have shown potential benefit of these programs, 4, 8, 9 with a large controlled trial ( n = 86) indicating significant benefit for a structured program of ten session memory training program. 4 – 6 Unfortunately, this is a costly approach and daily or weekly visits to the clinic are often not feasible for individuals living with MS. Traditionally, this approach has required the patient to travel to the clinic for multiple one-to-one sessions with a clinician or group. 1, 2Ĭognitive remediation is a behaviorally-based approach that offers many treatment advantages. 1 – 3 Cognitive impairment can exact a major toll on overall quality of life, compromising employment and relationships. Cognitive impairment is a critical concern for individuals living with multiple sclerosis (MS), affecting at least 40% of adult and 30% of pediatric patients.
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