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Cognitive Rehabilitation and Exercise for Multiple Sclerosis (COMBINE Trial)

N/A

Recruiting

Led By Carly Wender, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be relapse and steroid-free for at least 30 days

Moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS)

Must not have

History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)

Currently use medications that may impact cognition (ex: steroids, benzodiazepines)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1 and 2 (pre-intervention) and weeks 15 and 16 (post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a combination of cognitive rehabilitation and exercise can improve new learning and memory in people with multiple sclerosis and mobility issues.

Who is the study for?

This trial is for adults aged 18-70 with Multiple Sclerosis, who primarily speak English and have moderate mobility issues but are currently inactive. They must not have had a relapse or taken steroids in the last month and should be right-handed. People with other neurological disorders, uncontrolled psychiatric conditions, contraindications to exercise, certain medications affecting cognition, pregnancy, or MRI contraindications cannot participate.

What is being tested?

The study tests if combining cognitive rehabilitation (using Kessler Foundation's modified Story Memory Technique) with physical exercises (stretching/toning and aerobic training enhanced by virtual reality) can improve new learning and memory in people with Multiple Sclerosis who also have mobility disabilities.

What are the potential side effects?

While specific side effects are not detailed here, participants may experience general discomforts associated with physical exercises such as muscle soreness or fatigue. Cognitive rehabilitation typically does not cause side effects but may include mental fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had a relapse or taken steroids in the last 30 days.

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I have some difficulty walking or moving around.

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I am between 18 and 70 years old.

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I have been diagnosed with MS by a neurologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no neurological disorders other than MS and my mental health is stable.

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I am taking medication that could affect my thinking or memory.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1 and 2 (pre-intervention) and weeks 15 and 16 (post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1 and 2 (pre-intervention) and weeks 15 and 16 (post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 and 2 (pre-intervention) and weeks 15 and 16 (post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in everyday memory

Change in objective new learning and memory (NLM).

Secondary study objectives

Change in hippocampal function

Change in hippocampal volume

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cognitive Rehabilitation + Stretching and ToningExperimental Treatment2 Interventions

In the cognitive rehabilitation and stretching and toning (S/T) exercise condition, participants will complete 12 weeks of supervised S/T activities 3 days per week over the 12 week period. For seven weeks, participants will only complete S/T. During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.

Group II: Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)Experimental Treatment2 Interventions

In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning/memory; IDEAL) three days per week over a 12 week period. For seven weeks, participants will only complete IDEAL. For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.

0 / 6Eligibility criteria met