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Behavioral Intervention
Cycling and Virtual Reality for Multiple Sclerosis (PACE-MS 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
Confirmed MS diagnosis by a neurologist
Moderate self-report mobility disability
Must not have
History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit only.
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing the effects of different types of virtual reality during cycling exercise on thinking speed in people with multiple sclerosis.
Who is the study for?
This trial is for English-speaking individuals with a confirmed MS diagnosis by a neurologist, who have been free of relapses and steroids for at least 30 days, and report moderate mobility disability. It excludes those with other neurological disorders or uncontrolled psychiatric conditions, contraindications to exercise, cognition-impacting medications use (like steroids), current pregnancy, severe cognitive impairment, high motion sickness likelihood or regular cyclists.
What is being tested?
The PACE-MS trial aims to compare the effects on processing/thinking speed in people with MS when they participate in cycling exercises combined with different types of virtual reality experiences.
What are the potential side effects?
While specific side effects are not listed for this intervention involving exercise and virtual reality, participants may experience general exercise-related discomforts such as muscle soreness or fatigue. Virtual reality may cause dizziness or nausea especially in those prone to motion sickness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MS by a neurologist.
Select...
I have some difficulty moving around on my own.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no neurological disorders other than MS and my mental health is stable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit only
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit only
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Modified Flanker Task (MFT)
Secondary study objectives
Baseline Symbol Digit Modalities Test (SDMT)
Baseline mobility disability
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cycling with Visually Stimulating VRExperimental Treatment1 Intervention
Cycling with virtual reality where I only have to look at the environment while I cycle.
Group II: Cycling with Cognitively Stimulating VRExperimental Treatment1 Intervention
Cycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment.
Group III: Cycling AloneActive Control1 Intervention
Cycling alone, with no virtual reality.
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
184 Previous Clinical Trials
11,245 Total Patients Enrolled
33 Trials studying Multiple Sclerosis
1,633 Patients Enrolled for Multiple Sclerosis
Consortium of Multiple Sclerosis CentersOTHER
8 Previous Clinical Trials
50,135 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
50,135 Patients Enrolled for Multiple Sclerosis
Carly Wender, PhDPrincipal InvestigatorKessler Foundation
1 Previous Clinical Trials
78 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
78 Patients Enrolled for Multiple Sclerosis