Health TrialsbyHealthPanel

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

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKessler Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)Experimental treatment 2 interventions
Group B: Cognitive Rehabilitation + Stretching and ToningExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in objective new learning and memory (NLM).

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.

Time frame
Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
2

Change in everyday memory

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.

Time frame
Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)

Secondary outcomes

1

Change in hippocampal volume

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.

Time frame
Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
2

Change in hippocampal function

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.

Time frame
Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kessler Foundation

Lead sponsor

National Multiple Sclerosis Society

Collaborator

Source ClinicalTrials.gov
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