Multiple SclerosisPACE-MSNCT06191380
Effects of Cycling and Virtual Reality on Thinking Speed in Persons With MS (PACE-MS)
A study testing PACE-MS in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PACE-MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (MS).
Read the 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
- Being tested
- PACE-MS
- Keywords
- Multiple Sclerosis, Leg Cycling, Virtual Reality, Mobility Disability, Processing Speed
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE-MSBehavioural
A single bout of cycling.
| Study group | Role | What they receive |
|---|---|---|
| Cycling Alone | Active comparator | Cycling alone, with no virtual reality. Receives: 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. Receives: 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. Receives: Behavioral: PACE-MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.
Secondary outcomes (2)
Baseline mobility disability
Mobility disability status will be measured with a neurological exam to get an EDSS score.
Measured: Baseline visit only
Baseline Symbol Digit Modalities Test (SDMT)
Processing speed will be measured with the SDMT as a more stable measure of processing speed.
Measured: Baseline visit only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start12 Feb 2024
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers
- Responsible party
- Principal investigator, Carly Wender, Kessler Foundation
- Investigators
- Carly Wender, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191380
- Sponsor's protocol ID
- R123723
- Acronym
- PACE-MS
- Status last verified
- Oct 2025
- First submitted
- 19 Dec 2023
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06191380
- Acronym / sponsor ID
- PACE-MS / R123723
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Leg Cycling, Virtual Reality, Mobility Disability, Processing Speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cycling Alone | Active comparator | Behavioral: PACE-MSCycling alone, with no virtual reality. |
| Cycling with Visually Stimulating VR | Experimental | Behavioral: PACE-MSCycling with virtual reality where I only have to look at the environment while I cycle. |
| Cycling with Cognitively Stimulating VR | Experimental | Behavioral: PACE-MSCycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACE-MSA single bout of cycling. | Behavioural | Cycling Alone, Cycling with Cognitively Stimulating VR, Cycling with Visually Stimulating VR |
Primary outcome
Modified Flanker Task (MFT)
Time frame: Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.
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.
2 secondary outcomes
Baseline mobility disability
Time frame: Baseline visit only
Baseline Symbol Digit Modalities Test (SDMT)
Time frame: Baseline visit only.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly Wender, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACE-MS in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Flanker Task (MFT) (time frame: Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.