NCT06197685 · Kessler Foundation
A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
(COMBINE)
What this study is about
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.
View original scientific description
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.
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)
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- East Hanover, New Jersey
Collaborators
National Multiple Sclerosis Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations