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

NCT06191380 | Completed

• 1 other identifier: R123723
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Leg Cycling; Virtual Reality; Mobility Disability; Processing Speed

Outcome Measures

Primary Outcomes (1)

• Modified Flanker Task (MFT)

  Response time on a computerized test is conceptualized as a measure of processing speed. Participants are tasked with identifying the direction of the central target stimulus that is flanked by either congruent (\<\<\<\<\<) or incongruent (\>\>\<\>\>) stimuli by pressing the correct keyboard key.

  Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.

Secondary Outcomes (2)

• Baseline mobility disability

  Baseline visit only

• Baseline Symbol Digit Modalities Test (SDMT)

  Baseline visit only.

Study Arms (3)

Cycling Alone

ACTIVE COMPARATOR

Cycling alone, with no virtual reality.

Behavioral: PACE-MS

Cycling with Visually Stimulating VR

EXPERIMENTAL

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

Behavioral: PACE-MS

Cycling with Cognitively Stimulating VR

EXPERIMENTAL

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

Behavioral: PACE-MS

Interventions

PACE-MS BEHAVIORAL

A single bout of cycling.

Cycling Alone; Cycling with Cognitively Stimulating VR; Cycling with Visually Stimulating VR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• Consortium of Multiple Sclerosis Centers: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Carly Wender, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be blinded to the hypothesized effect of each exercise condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: February 12, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)