Effects of Cycling and Virtual Reality on Thinking Speed in Persons With MS (PACE-MS)

NCT ID: NCT06191380

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2025-10-28

Brief Summary

To compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (MS).

Detailed Description

The purpose of this research study is to learn how different types of cycling exercise can improve short-term processing speed, or speed of thinking, in persons with MS. In this study, we will compare the effects of cycling alone to cycling with two different types of virtual reality. Participants will complete all three cycling conditions, one per week. We are studying these types of cycling because there are currently no effective treatment options to improve processing speed in persons with MS and combining exercise with virtual reality is a promising technique.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cycling Alone

Cycling alone, with no virtual reality.

Group Type: ACTIVE_COMPARATOR

PACE-MS

Intervention Type: BEHAVIORAL

A single bout of cycling.

Cycling with Visually Stimulating VR

Cycling with virtual reality where I only have to look at the environment while I cycle.

Group Type: EXPERIMENTAL

PACE-MS

Intervention Type: BEHAVIORAL

A single bout of cycling.

Cycling with Cognitively Stimulating VR

Cycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment.

Group Type: EXPERIMENTAL

PACE-MS

Intervention Type: BEHAVIORAL

A single bout of cycling.

Interventions

PACE-MS

A single bout of cycling.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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-report mobility disability

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
• Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
• No indication of age-related mild cognitive impairment or dementia, based on the MOCA-Blind (i.e., MOCA-Blind ≥19).
• High likelihood of motion sickness
• Regular cyclist, defined as cycling for at least 150 minutes/week

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consortium of Multiple Sclerosis Centers

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Carly Wender

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carly Wender, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

R123723

Identifier Type: -

Identifier Source: org_study_id