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Kessler Foundation Strategy-Based Training to Enhance Memory (KF-STEM™): Study protocol for a single site
Nancy D Chiaravalloti1,2, Erica Weber1,2, Ekaterina Dobryakova1,2
1Kessler Foundation, Center for Neuropsychology and Neuroscience Research, East Hanover, NJ, USA.
Contemporary Clinical Trials Communications
|November 17, 2022
Summary
New cognitive rehabilitation, Kessler Foundation Strategy-based Training to Enhance Memory (KF-STEM™), shows promise for improving learning and memory in Multiple Sclerosis (MS) patients. This study provides Class I evidence for KF-STEM™ efficacy in treating MS-related cognitive deficits.
Area of Science:
- Neuroscience
- Cognitive Rehabilitation
- Clinical Trials
Background:
- Learning and memory impairments are prevalent in Multiple Sclerosis (MS), significantly affecting daily functioning.
- There is a critical need for evidence-based cognitive rehabilitation strategies for individuals with MS.
- Current treatment options for MS-related cognitive deficits often lack robust scientific validation (Class I evidence).
Purpose of the Study:
- To evaluate the efficacy of the Kessler Foundation Strategy-based Training to Enhance Memory (KF-STEM™) protocol in treating learning and memory impairments in persons with MS.
- To provide Class I evidence for a cognitive rehabilitation protocol for individuals with MS.
- To assess the long-term effects of KF-STEM™ and the impact of booster sessions on cognitive function and daily living.
Main Methods:
- A double-blind, placebo-controlled randomized clinical trial (RCT) involving 120 participants with clinically definite MS and learning/memory impairments.
- An 8-session KF-STEM™ protocol training participants in self-generation, spaced learning, and retrieval practice.
- Outcome assessments included global functioning, neuropsychological evaluation, and functional Magnetic Resonance Imaging (fMRI), with a 6-month follow-up.
Main Results:
- The study is designed to provide Class I evidence for the KF-STEM™ treatment protocol.
- Functional Magnetic Resonance Imaging (fMRI) will be used to investigate treatment-related changes in cerebral activation patterns.
- The research will determine the sustained efficacy of KF-STEM™ on cognitive performance and everyday functioning.
Conclusions:
- The rigorous methodology of this study is expected to yield high-level evidence for KF-STEM™.
- KF-STEM™ has the potential to be a valuable, evidence-based intervention for cognitive rehabilitation in Multiple Sclerosis.
- Findings will inform clinical practice and enhance the quality of life for individuals affected by MS-related cognitive impairments.
