A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®), Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL), Stretching and Toning (S/T).
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.
Detailed description
The proposed research study will be the first to apply the Kessler Foundation modified Story Memory Technique (KF-mSMT®), the practice standard for cognitive rehabilitation, with one of two exercise programs. Alone, KF-mSMT® has been beneficial to NLM impairment, however, its effects are highly selective to list learning and as such, will not maximally restore NLM function. The combination of KF-mSMT® and exercise provides a robust approach towards maximal functional recovery.
Interventions
- Behavioral The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)
KF-mSMT is a memory retraining technique that consists of two-related skills: (1) imagery and (2) context/organization. The proposed KF-mSMT intervention includes 10 total sessions with 2 sessions per week for 5 weeks. Each session will last 45-60 minutes. - Behavioral Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)
The AET condition includes 12 weeks of supervised, progressive, moderate intensity cycle ergometry. The AET will include semi-immersive, interactive VR such the cycling speed on the bike will translate directly to perceived speed through the virtual environment. - Behavioral Stretching and Toning (S/T)
The S/T condition will include 12 weeks of supervised S/T activities that target the head/neck. shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.
Primary outcome measures
- Change in objective new learning and memory (NLM). [Time frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]
- Change in everyday memory [Time frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]
Secondary outcome measures (2)
- Change in hippocampal volume [Time frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]
- Change in hippocampal function [Time frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]
Eligibility criteria
Inclusion criteria
- Be within the ages of 18 and 70 years of age
- Speak English as their primary language
- Confirmed MS diagnosis by a neurologist
- Be relapse and steroid-free for at least 30 days
- Mild-to-moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS)
- Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ)
- Right handedness
Exclusion criteria
- History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
- Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
- Currently use medications that may impact cognition (ex: steroids, benzodiazepines)
- Currently pregnant
- Contraindication for MRI (metal or electronic devices in the body that are not considered MRI safe)
- Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kessler Foundation — East Hanover
Identifiers
NCT: NCT06197685 · R123323