Dataset Information

An RCT to treat learning impairment in multiple sclerosis: The MEMREHAB trial.

ABSTRACT:

Objective

To examine the efficacy of the modified Story Memory Technique (mSMT), a 10-session behavioral intervention teaching context and imagery to facilitate learning, to improve learning and memory abilities in persons with multiple sclerosis (MS).

Methods

This double-blind, placebo-controlled, randomized clinical trial included 86 participants with clinically definite MS, 41 in the treatment group and 45 in the placebo control group. Participants completed a baseline neuropsychological assessment, including questionnaires assessing everyday memory, a repeat assessment immediately posttreatment, and a long-term follow-up assessment 6 months after treatment. After completion of the treatment phase, persons in the treatment group were assigned to a booster session or a non-booster session group to examine the efficacy of monthly booster sessions in facilitating the treatment effect over time.

Results

The treatment group showed a significantly improved learning slope relative to the placebo group posttreatment. Similar results were noted on objective measures of everyday memory, general contentment, and family report of apathy and executive dysfunction. Long-term follow-up data showed that posttreatment improvement in the treatment group continued to be noted on the list learning and self-report measures. The provision of booster sessions demonstrated little benefit.

Conclusion

The mSMT is effective for improving learning and memory in MS.

Classification of evidence

This study provides Class I evidence that the mSMT behavioral intervention improves both objective memory and everyday memory in patients with MS over 5 weeks, with treatment effects lasting over a 6-month period.

SUBMITTER: Chiaravalloti ND

PROVIDER: S-EPMC3863346 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:This randomised controlled trial (RCT) examines treadmill walking exercise training effects on learning and memory performance, hippocampal volume, and hippocampal resting-state functional connectivity in persons with multiple sclerosis (MS) who have objective impairments in learning new information. METHODS AND ANALYSIS:Forty fully ambulatory persons with MS who demonstrate objective learning and memory impairments will be randomly assigned into either the intervention or active control study conditions. The intervention condition involves supervised, progressive treadmill walking exercise training three times per week for a 3-month period. The active control condition involves supervised, progressive low-intensity resistive exercise that will be delivered at the same frequency as the intervention condition. The primary outcome will involve composite performance on neuropsychological learning and memory tests, and the secondary outcomes involve MRI measures of hippocampal volume and resting-state functional connectivity administered before and after the 3-month study period. Outcomes will be administered by treatment-blinded assessors using alternate test forms to minimise practice effects, and MRI data processing will be performed by blinded data analysts. ETHICS AND DISSEMINATION:This study has been approved by a university institutional review board. The primary results will be disseminated via peer-reviewed publications and the final data will be made available to third parties in applicable data repositories. If successful, the results from this study will eventually inform subsequent RCTs for developing physical rehabilitation interventions (ie, treadmill walking exercise training) for improving learning and memory and its relationship with hippocampal outcomes in larger samples of cognitively impaired persons with MS. The results from this early-phase RCT will further lay preliminary groundwork for ultimately providing clinicians and patients with guidelines for better using chronic treadmill walking exercise for improving cognition and brain health. This approach is paramount as learning and memory impairment is common, burdensome and poorly managed in MS. TRIAL REGISTRATION NUMBER:NCT03319771; Pre-results.