Kessler Foundation Strategy-Based Training to Enhance Memory (KF-STEM™): Study protocol for a single site double-blind randomized, clinical trial in Multiple Sclerosis

Abstract

New learning and memory impairments are common in Multiple Sclerosis (MS) and negatively impact everyday life, including occupational and social functioning. Despite the demand for learning and memory treatments, few cognitive rehabilitation protocols are supported by Class I research evidence, limiting the degree to which effective treatments may be utilized with persons with MS. The present double-blind, placebo controlled randomized clinical trial (RCT) examines the efficacy of an 8-session cognitive rehabilitation protocol encompassing training in the application of three strategies with the strongest empirical evidence (self-generation, spaced learning and retrieval practice) to treat impaired learning and memory in persons with MS, Kessler Foundation Strategy-based Training to Enhance Memory (KF-STEM™).A sample of 120 participants with clinically definite MS who have impairments in new learning and memory will be enrolled. Outcomes will be assessed via three mechanisms, an Assessment of Global Functioning, which examines everyday functioning and quality of life, a Neuropsychological Evaluation to examine objective cognitive performance, and functional Magnetic Resonance Imaging to examine the impact of treatment on patterns of cerebral activation. We will additionally evaluate the longer-term efficacy of KF-STEM™ on everyday functioning and neuropsychological assessment through a 6-month follow-up evaluation and evaluate the impact of booster sessions in maintaining the treatment effect over time. The methodologically rigorous design of the current study will provide Class I evidence for the KF-STEM™ treatment protocol for persons with MS.