A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06197685
• Lead Sponsor: Kessler Foundation

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Study Start: 2024-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in objective new learning and memory (NLM).	Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)	The California Verbal Learning Test-Second Edition (CVLT-II) measures verbal learning and memory by having participants recall a list of words from 4 semantic categories. The word list is presented over 5 trials with a 20 minute delayed recall and recognition trial. Standardized T-scores range from 0-100, where higher scores indicated better performance.
Change in everyday memory	Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)	The Ecological Memory Simulations (EMS) is a multi-component test that measures memory as it relates to everyday life. Scores range from 0-205, where higher scores indicated better performance.

Secondary Outcome Measures

Name	Time	Method
Change in hippocampal volume	Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)	MRI data will be collected in the Rocco Ortenzio Neuroimaging Center at Kessler Foundation using an FDA-approved 3.0 T Siemens Skyra scanner and a 32-channel head coil to measure the volume of bilateral hippocampi.
Change in hippocampal function	Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)	fMRI data will be collected during a list-learning task conducted while in the FDA-approved 3.0 T Siemens Skyra scanner with a 32-channel head coil.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States