Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06197685

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

Led by Kessler Foundation · Updated on 2025-09-02

78

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Kessler Foundation

Lead Sponsor

N

National Multiple Sclerosis Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the combined effects of cognitive rehabilitation and exercise on new learning and memory in people with multiple sclerosis (MS) who have mobility disability. This study aims to evaluate whether combining the Kessler Foundation modified Story Memory Technique (KF-mSMT), a memory retraining program, with exercise can better restore learning and memory functions compared to cognitive rehabilitation alone. The study compares two types of exercise paired with KF-mSMT to support maximal functional recovery. Participants will be randomly assigned to one of two groups for 12 weeks. One group will perform aerobic exercise training with virtual reality (IDEAL) three days a week, doing only IDEAL for the first seven weeks and then adding KF-mSMT two days a week for the last five weeks. The other group will do supervised stretching and toning exercises three days a week for 12 weeks, with the same schedule for adding KF-mSMT in weeks 8 to 12. During the study, participants will be assessed on new learning and memory, everyday memory, and hippocampal volume and function before and after the intervention (at weeks 1-2 and 15-16). The study involves supervised exercise sessions, cognitive training, and various memory and brain function tests to measure changes. The total participation duration is about 16 weeks, including pre- and post-intervention assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 70 years old
  • Speak English as your primary language
  • Have a confirmed diagnosis of multiple sclerosis by a neurologist
  • Be relapse and steroid-free for at least 30 days
  • Have mild-to-moderate mobility disability based on the Patient Determined Disease Steps scale
  • Be currently physically inactive according to the Godin Leisure Time Exercise Questionnaire
  • Be right handed
Not Eligible

You will not qualify if you...

  • History of neurological disorders other than multiple sclerosis or uncontrolled psychiatric disorders such as major depression
  • Have contraindications to exercise based on the Physical Activity Readiness Questionnaire
  • Currently use medications that may affect cognition, such as steroids or benzodiazepines
  • Currently pregnant
  • Have contraindications for MRI, such as metal or electronic devices in the body that are not MRI safe
  • Have severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants complete either 12 weeks of aerobic exercise training with virtual reality or stretching and toning activities three days per week. During weeks 8 to 12, participants also complete the Kessler Foundation modified Story Memory Technique (KF-mSMT®) memory retraining program two days per week.

3 supervised exercise sessions per week plus 2 memory training sessions per week during weeks 8 to 12

Follow-up

Duration - 2 weeks

Participants are assessed for changes in new learning and memory, everyday memory, hippocampal volume, and hippocampal function after completing the intervention.

1 to 2 visits (in-person) for post-intervention assessments

Trial Site Locations

Total: 1 location

1

Kessler Foundation

East Hanover, New Jersey, United States, 07936

Actively Recruiting

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Research Team

C

Carly Wender, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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