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

Multiple Sclerosis Clinical Trial

— PACE-MS  

Official title:

Effects of a Single Bout of Moderate Intensity Aerobic Cycling Exercise Combined With Virtual Reality on Processing Speed in Persons With Multiple Sclerosis and Mobility Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191380
• Other study ID #: R123723
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Kessler Foundation
• Contact: Carly Wender, PhD
• Phone: 9733248388
• Email: cwender[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Speak English as their primary language

• Confirmed MS diagnosis by a neurologist

• Be relapse and steroid-free for at least 30 days

• 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)

• High likelihood of motion sickness

• Regular cyclist, defined as cycling for at least 150 minutes/week

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• PACE-MS
A single bout of cycling.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Consortium of Multiple Sclerosis Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline mobility disability	Mobility disability status will be measured with a neurological exam to get an EDSS score.	Baseline visit only
Secondary	Baseline Symbol Digit Modalities Test (SDMT)	Processing speed will be measured with the SDMT as a more stable measure of processing speed.	Baseline visit only.