Clinical trial NCT05878873: The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Official title: The Neural Underpinnings and the Impact of Wearable Sensory Stimulation During Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: split-belt treadmill
adaptation
multiple sclerosis
functional near-infrared spectroscopy
cortical activation
gait asymmetry
locomotion
sensorimotor control
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2023-05-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Most people with MS (PwMS) experience significant gait asymmetries between the two legs leading to an increased risk of falls and musculoskeletal injury. The objective of this study is to investigate the neural mechanisms of gait adaptation and the effects of transcutaneous electrical nerve stimulation (TENS) on adaptability during split-belt treadmill training in PwMS. Our hypothesis is that TENS will strengthen sensorimotor integration via amplified afferent signaling, thereby enhancing adaptation, and further improving gait symmetry chronically. Functional near-infrared spectroscopy (fNIRS) will be used during a split-belt treadmill training paradigm to assess cortical activation during gait adaptation. Additionally, the effect of split-belt treadmill training coupled with TENS on gait adaptability in PwMS will be tested with experimental and a sham TENS split-belt treadmill sessions. Cortical activation and the effect of TENS on gait adaptability will be compared between young neurotypical adults and PwMS to assess differences that can be attributed to multiple sclerosis.

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

Primary outcomes:
measure: Change in Cortical Hemodynamics
timeFrame: Baseline session 1 (day 1), training session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), training session 2, and post-training session 2 (day 14)
measure: Change in Step Length Asymmetry
timeFrame: Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)
measure: Rate of Step Length Asymmetry Adaptation
timeFrame: Adaptation session 1 (day 1), and adaptation session 2 (day 14)
Secondary outcomes:
measure: Change in Phase Coordination Index
timeFrame: Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)
measure: Change in Double Support Percent
timeFrame: Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: The Sensorimotor Neuroimaging Laboratory
state: Colorado
Study officials:
affiliation: Colorado State University
name: Brett W Fling, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: