A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study

Abstract

Objective: To assess whether a videogame-like digital treatment is superior to a control in improving processing speed in adults with multiple sclerosis (MS). Methods: Adults with MS and baseline Symbol Digit Modalities Test (SDMT) z-scores between −2 and 0 were enrolled in a double-blind randomized controlled clinical trial. After completing a baseline in-clinic evaluation (Visit 1), they were randomized to complete an in-home, tablet-based videogame-like digital treatment (AKL-T03) or control word game (AKL-T09) for up to 25 minutes/day, 5 days/week, for 6 weeks. A repeat in-clinic evaluation occurred at 6 weeks (Visit 2), and again 8 weeks later to determine persistence of effects (Visit 3). The pre-specified primary outcome was change in SDMT score between Visits 1 and 2. Results: SDMT increased at Visit 2 for participants randomized to both AKL-T03 ( p < 0.001) and AKL-T09 ( p = 0.024). These respective mean improvements were +6.10 and +3.55 (comparison p = 0.21). At Visit 3, 70% of participants randomized to AKL-T03 maintained a clinically meaningful 4+-point increase in SDMT above their baseline, compared with 37% for AKL-T09 ( p = 0.038). Conclusion: This in-home digital intervention resulted in substantial and durable improvements in processing speed. A larger randomized controlled clinical trial is planned. Trial Registration: This trial is registered on ClinicalTrials.gov under “NCT03569618,” https://clinicaltrials.gov/ct2/show/NCT03569618 .

Application of an Adaptive, Digital, Game-Based Approach for Cognitive Assessment in Multiple Sclerosis: Observational Study (Preprint)

“…A group of 24 adults without MS (non-MS) (mean age: 46.0, SEM 3.72 years) with no chronic autoimmune diseases were also recruited from the UCSF staff, willing family members of patients in the clinic, and other eligible and willing volunteers. All participants with MS were recruited as part of studies to determine the feasibility [18] and preliminary efficacy [17] of the EVO platform as a digital therapeutic to improve processing speed in people with MS. The analysis of this study was based on baseline performance data (ie, before any cognitive intervention) of our feasibility [18] and efficacy [17] trials.…”

“…All participants with MS were recruited as part of studies to determine the feasibility [18] and preliminary efficacy [17] of the EVO platform as a digital therapeutic to improve processing speed in people with MS. The analysis of this study was based on baseline performance data (ie, before any cognitive intervention) of our feasibility [18] and efficacy [17] trials. All procedures performed in the study involving human participants were approved by the Committee for Human Research at the University of California, San Francisco.…”

“…This approach can mitigate potential ceiling and floor effects when interindividual variability is high, and leads to more reliable assessments that can be completed in a timely manner [8,16]. Furthermore, digital tools can be easily applied in different settings, including patients' homes, which substantially improves health care accessibility for patients who have difficulties with travel to the clinic due to cognitive or physical disabilities [14,17,18].…”

“…We previously evaluated whether a video game-based digital tool, EVO-AKL-T01 (Akili), could improve cognition in MS [17,18]. After these studies, we looked to better characterize cognitive function using similar tools based on these cognitive therapeutics.…”

“…Although our analyses were exploratory, the observed correlations support the need to better understand how EVO Monitor performance is associated with physical performance and the structural and functional changes of the brain in people with MS. Specifically, studies with functional MRI and connectivity data would provide essential information about neural correlates of the EVO Monitor tasks and, more importantly, pathological changes related to CI and neural plastic changes as a result of cognitive remediation.Previously, we showed that EVO-AKL-T01, a video game-based digital tool similar to EVO Monitor, is an effective in-home cognitive remediation program for MS[17,18]. The high adherence rate during the 4-to 6-week home-based cognitive rehabilitation strategy indicated that remote digital tools are well accepted by patients with MS, who may have limited access to cognitive assessment or treatment.…”