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NCT Number: NCT06197685

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

Location contact

Carly Wender, PhD

CONTACT

[email protected]

9732436984

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

Behavioral

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.

Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)

Behavioral

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.

Other names: IDEAL

Stretching and Toning (S/T)

Behavioral

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 outcomes

  1. Change in objective new learning and memory (NLM).

    Time frame: 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.

  2. Change in everyday memory

    Time frame: 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 outcomes

  1. Change in hippocampal volume

    Time frame: 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.

  2. Change in hippocampal function

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carly Wender, PhD

CONTACT

[email protected]

(973) 324-8388

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Acronym: COMBINE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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