Motor Learning for Multiple Sclerosis

(STRES-MS Trial)

Overseen By Feng Yang, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Psychiatric, Neurological, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

64 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this interventional study is to examine the overall motor learning capacity from exposure to repeated perturbations among ambulatory people with multiple sclerosis (MS). This project will advance our understanding of learning new motor skills from exposure to external perturbations. If it is proven that people with MS can learn motor skills from perturbation training, the findings from this study will pave a theoretical foundation for applying perturbation training as a promising fall prevention intervention for people with MS.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Perturbation Training for Multiple Sclerosis?

Research shows that people with multiple sclerosis (MS) can still experience changes in their brain that help them adapt and improve motor skills, even though these changes might be less effective than in healthy individuals. This suggests that treatments like Perturbation Training, which focus on motor learning, could help MS patients by promoting these adaptive changes in the brain. ^{1 2 3 4 5}

Is motor learning or perturbation training safe for humans?

The research does not provide specific safety data for motor learning or perturbation training in humans, but it discusses the potential for these approaches to aid in recovery by promoting brain plasticity in multiple sclerosis patients. ^{1 2 5 6 7}

How does the treatment Perturbation Training differ from other treatments for multiple sclerosis?

Perturbation Training is unique because it focuses on enhancing the brain's ability to reorganize and adapt through motor learning, which is crucial for compensating for brain injury in multiple sclerosis. Unlike standard treatments that primarily aim to reduce inflammation or manage symptoms, this approach leverages the brain's plasticity (ability to change and adapt) to improve motor function. ^{1 3 4 5 8}

Eligibility Criteria

This trial is for ambulatory individuals with Multiple Sclerosis (MS) who can walk and are interested in learning fall-resistant skills. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

I can stand on my own for at least 30 seconds.

Montreal Cognitive Assessment score of 23 or higher

Free from pregnancy

Exclusion Criteria

I do not have severe psychiatric, neurological, or heart conditions.

My condition worsened in the last 8 weeks.

Previous experience with perturbation training

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acquisition Session

Participants undergo initial training with perturbation or control walking on a treadmill, followed by an unexpected slip and trip overground

1 session

1 visit (in-person)

Retention Sessions

Participants experience treadmill and overground slip and trip perturbations at 3-month and 6-month intervals

6 months

2 visits (in-person)

Follow-up

Participants are monitored for real-life falls and near falls through weekly online surveys

6 months

Treatment Details

Interventions

• Perturbation Training

Trial Overview The study tests if people with MS can improve their balance and reduce falls by learning motor skills through repeated slip or trip exposures. Participants will undergo perturbation training and treadmill walking to assess their motor learning capacity.

Participant Groups

Group I: Training Group Experimental Treatment 1 Intervention

During the acquisition session, this group will undergo perturbation training on the treadmill while wearing a safety harness. Then, they will experience an unexpected slip and trip while wearing a safety harness and walking overground. During the 3-month and 6-month retention sessions, they will experience a slip and trip during treadmill walking and a slip and trip during overground walking.

Group II: Control Group Active Control 1 Intervention

During the acquisition session, this group will walk on the treadmill without perturbations for the same amount of time as the training group. Then, they will experience an unexpected slip and trip while wearing a safety harness and walking overground. During the 3-month and 6-month retention sessions, they will experience a slip and trip during treadmill walking and a slip and trip during overground walking.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

Plasticity of the motor system in multiple sclerosis. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Rapid-onset central motor plasticity in multiple sclerosis. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Adaptive cortical changes and the functional correlates of visuo-motor integration in relapsing-remitting multiple sclerosis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Training-dependent plasticity in patients with multiple sclerosis. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Practice-dependent motor cortex plasticity is reduced in non-disabled multiple sclerosis patients. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of inflammation and its reduction on brain plasticity in multiple sclerosis: MRI evidence. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Altered functional connectivity during performance feedback processing in multiple sclerosis. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Plasticity of the motor system in multiple sclerosis]. [2009]