N/A
N=51
The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05878873 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Cortical Activation — 0.054; -0.024; 0.074; -0.016 Unitless GLM beta weight (HbO) — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Split-belt Treadmill (Behavioral); Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cortical Activation |
0.054; -0.024; 0.074; -0.016 | 0.007 sig |
| PRIMARY Change in Adaptation Savings |
0.0032; 0.0451; 0.0221; 0.0278 | 0.014 sig |
| PRIMARY Rate of Step Length Asymmetry Adaptation |
-0.090; -0.088; -0.095; -0.103 | 0.898 |
Summary
Majority of people with multiple sclerosis experience difficulty with balance and mobility, leading to an increased risk of falls. The goal of this clinical trial is to learn about brain activity during walking adaptation in people with multiple sclerosis. Also, this clinical trial will test a form of nerve stimulation to see if it can improve walking performance.
The main questions it aims to answer are:
* What areas of the brain are the most active during walking adaptation?
* Can nerve stimulation make walking adaptation more effective?
Participants will walk on a treadmill where each leg will go a different speed which will create walking adaptation. At the same time, brain scans will occur. There will be two sessions of walking adaptation, one with nerve stimulation, and one without nerve stimulation. Researchers will compare people with multiple sclerosis to healthy young adults to see if there are differences in brain activity.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of relapsing remitting multiple sclerosis OR a neurotypical adult (ages 18-86)
- Not experiencing an active relapse
- Able to stand and walk without an assistive device
- Able to walk for three tenths of a mile without stopping to rest
Exclusion Criteria
- Unable to walk for three tenths of a mile without assistance
- Musculoskeletal injury in past 6 months
- Lower extremity surgery in past 6 months
- Unable to abstain from medications that impair balance
- Currently pregnant
- History of traumatic brain injury
- History of vestibular disease
- History of any other balance impairment unrelated to multiple sclerosis
Data sourced from ClinicalTrials.gov (NCT05878873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.