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Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR) 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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

COMBINE Trial 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.Check my eligibility

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.See study design

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.

COMBINE Trial 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.

COMBINE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in everyday memory

Change in objective new learning and memory (NLM).

Secondary outcome measures

Change in hippocampal function

Change in hippocampal volume

COMBINE 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Multiple Sclerosis SocietyOTHER

95 Previous Clinical Trials

9,405 Total Patients Enrolled

93 Trials studying Multiple Sclerosis

9,051 Patients Enrolled for Multiple Sclerosis

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,660 Total Patients Enrolled

32 Trials studying Multiple Sclerosis

1,539 Patients Enrolled for Multiple Sclerosis

Carly Wender, PhDPrincipal InvestigatorKessler Foundation

1 Previous Clinical Trials

24 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

24 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing research study?

"According to the information available on clinicaltrials.gov, this specific trial is not currently seeking participants. The initial posting of this study was made on January 1st, 2024, and it was last updated on December 26th, 2023. However, there are currently a total of 524 other trials actively enrolling patients at present."

Answered by AI

Is the age threshold for participation in this medical study inclusive of individuals aged 65 and above?

"To be eligible for this research study, participants must satisfy the age requirements of being at least 18 years old and no more than 70 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06197685.