Multiple SclerosisEarly Phase 1PRIMERSNCT06233370
Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis
A Early Phase 1 study testing Moderate intensity walking exercise in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
The project will involve a within-subjects, repeated-measures research design. Participants will initially be screened for relevant inclusion/exclusion criteria for maximizing safety of participating in an exercise study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Moderate intensity walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically-definite MS diagnosis
- Relapse-free for at least 30 days
- Low risk for contraindications for exercise testing
- Low risk for contraindications for MRI
- Historically physically inactive prior to MS diagnosis
- Historically highly physically active prior to MS diagnosis
Who cannot join
- Diagnosis of uncontrolled major depressive disorder, schizophrenia, bipolar disorder I or II, or substance use disorders
- Taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
- Historically moderately physically active prior to MS diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
The project will involve a within-subjects, repeated-measures research design. Participants will initially be screened for relevant inclusion/exclusion criteria for maximizing safety of participating in an exercise study. If a participant meets those inclusion/exclusion criteria, they will visit Kessler Foundation three times. The first visit will involve a baseline session where participants will complete several cognitive tests. This will be followed by a training session, where participants will be provided with a FitBit, and will be trained by research staff to walk at a rate of 100 steps per minute. Once participants demonstrate proficiency at walking at this rate using the FitBit, participants will complete several questionnaires, followed by a maximal, graded exercise test to determine cardiorespiratory fitness. One week later, participants will return to Kessler Foundation to complete 1 of 2 experimental sessions that will be delivered in a random order that further will be counterbalanced across participants (to minimize the potential effects of session order on brain function and blood flow, respectively). Both experimental sessions will follow the same structure. First, participants will undertake a 30-minute MRI scan at Kessler Foundation to measure brain function and brain blood flow. Immediately following the MRI scan, participants will engage in either 20 minutes of treadmill walking exercise or 20 minutes of overground walking exercise at a rate of 100 steps per minute. Immediately following the 20-minute exercise bouts, participants will undertake another MRI scan for measuring brain function and brain blood flow. Participants will return to Kessler Foundation a third time to complete the opposite experimental session that was not completed during the second visit (i.e., overground walking exercise if treadmill walking exercise was completed during the second visit). In total, each participant will undergo four MRI scans over the course of the study (i.e., pre-treadmill, post-treadmill, pre-overground, post-overground). .
- Conditions
- Multiple Sclerosis
- Being tested
- Moderate intensity walking exercise
- Keywords
- exercise, MRI, walking
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity walking exerciseBehavioural
For each intervention arm, participants will be walking at a moderate intensity, determined based on a step rate of approximately 100 steps per minute (measured by a Fitbit)
| Study group | Role | What they receive |
|---|---|---|
| Over ground walking exercise | Experimental | Participants will walk around a square hallway at a step rate of ~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps. Receives: Behavioral: Moderate intensity walking exercise |
| Treadmill walking exercise | Experimental | Participants will walk on a motor-driven treadmill at a step rate of ~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps. Receives: Behavioral: Moderate intensity walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Function
MRI-measured resting-state functional connectivity of the thalamus with other areas of the brain
Measured: Weeks 2 and 3
Brain Blood Flow
MRI-measured cerebral blood flow perfusion in the left and right hemispheres
Measured: Weeks 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Mar 2024
- Primary completion28 Feb 2025
- Study completion31 Dec 2026 (estimated)
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.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete two single bouts of walking exercise. One bout of walking exercise involves walking at a moderate intensity over ground, and the other bout of walking exercise involves walking at a moderate intensity on a treadmill. The order of walking exercise bouts will be randomly determined and counterbalanced across participants. Before and after each bout of walking exercise, participants will complete an MRI scan to measure brain connectivity and brain blood flow.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Sandroff, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233370
- Sponsor's protocol ID
- R-1234-23
- Acronym
- PRIMERS
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share de-identified IPD upon request for inclusion in potential meta-analyses
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06233370
- Acronym / sponsor ID
- PRIMERS / R-1234-23
- Conditions
- Multiple Sclerosis
- Keywords
- exercise, MRI, walking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 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.
The project will involve a within-subjects, repeated-measures research design. Participants will initially be screened for relevant inclusion/exclusion criteria for maximizing safety of participating in an exercise study. If a participant meets those inclusion/exclusion criteria, they will visit Kessler Foundation three times. The first visit will involve a baseline session where participants will complete several cognitive tests. This will be followed by a training session, where participants will be provided with a FitBit, and will be trained by research staff to walk at a rate of 100 steps per minute. Once participants demonstrate proficiency at walking at this rate using the FitBit, participants will complete several questionnaires, followed by a maximal, graded exercise test to determine cardiorespiratory fitness. One week later, participants will return to Kessler Foundation to complete 1 of 2 experimental sessions that will be delivered in a random order that further will be counterbalanced across participants (to minimize the potential effects of session order on brain function and blood flow, respectively). Both experimental sessions will follow the same structure. First, participants will undertake a 30-minute MRI scan at Kessler Foundation to measure brain function and brain blood flow. Immediately following the MRI scan, participants will engage in either 20 minutes of treadmill walking exercise or 20 minutes of overground walking exercise at a rate of 100 steps per minute. Immediately following the 20-minute exercise bouts, participants will undertake another MRI scan for measuring brain function and brain blood flow. Participants will return to Kessler Foundation a third time to complete the opposite experimental session that was not completed during the second visit (i.e., overground walking exercise if treadmill walking exercise was completed during the second visit). In total, each participant will undergo four MRI scans over the course of the study (i.e., pre-treadmill, post-treadmill, pre-overground, post-overground). .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will complete two single bouts of walking exercise. One bout of walking exercise involves walking at a moderate intensity over ground, and the other bout of walking exercise involves walking at a moderate intensity on a treadmill. The order of walking exercise bouts will be randomly determined and counterbalanced across participants. Before and after each bout of walking exercise, participants will complete an MRI scan to measure brain connectivity and brain blood flow.
| Arm | Type | Receives |
|---|---|---|
| Over ground walking exercise | Experimental | Behavioral: Moderate intensity walking exerciseParticipants will walk around a square hallway at a step rate of ~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps. |
| Treadmill walking exercise | Experimental | Behavioral: Moderate intensity walking exerciseParticipants will walk on a motor-driven treadmill at a step rate of ~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically-definite MS diagnosis
- Relapse-free for at least 30 days
- Low risk for contraindications for exercise testing
- Low risk for contraindications for MRI
- Historically physically inactive prior to MS diagnosis
Key exclusion criteria (3 listed)
- Diagnosis of uncontrolled major depressive disorder, schizophrenia, bipolar disorder I or II, or substance use disorders
- Taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
- Historically moderately physically active prior to MS diagnosis
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 |
|---|---|---|
| Moderate intensity walking exerciseFor each intervention arm, participants will be walking at a moderate intensity, determined based on a step rate of approximately 100 steps per minute (measured by a Fitbit) | Behavioural | Over ground walking exercise, Treadmill walking exercise |
Primary outcome
Brain Function
Time frame: Weeks 2 and 3
MRI-measured resting-state functional connectivity of the thalamus with other areas of the brain
Brain Blood Flow
Time frame: Weeks 2 and 3
MRI-measured cerebral blood flow perfusion in the left and right hemispheres
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Undecided. We will share de-identified IPD upon request for inclusion in potential meta-analyses
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Moderate intensity walking exercise 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Brain Function (time frame: Weeks 2 and 3). The study lists 2 primary outcomes in all. 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 6 Aug 2026.